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Investigating the Effect of Caffeine and Alcohol on Pupil Dynamics (PAC)

28 maggio 2026 aggiornato da: Raymond P. Najjar, PhD, National University of Singapore

Investigating the Effect of Caffeine and Alcohol on Pupil Dynamics (PAC)

The goal of this study is to understand how caffeine and alcohol affect the ocular and physiological systems, especially how the pupil (the aperture in the colored part of the eye) responds to light. It will also test whether these changes can be used to detect recent caffeine or alcohol intake using a portable eye device.

The main questions it aims to answer are:

  1. How does caffeine change pupil responses, eye movements, and other ocular and physiological measurements?
  2. How does alcohol change these same ocular and physiological responses?
  3. Are the effects of caffeine and alcohol different from each other?
  4. Can these changes be used to accurately identify whether someone has consumed caffeine or alcohol?

Researchers will compare caffeine, alcohol, and a placebo (a look-alike drink with no active substance) to see how each affects the ocular and physiological outcomes.

Participants will:

  1. Attend three separate sessions where they will consume caffeine, alcohol, or a placebo (in random order)
  2. Undergo pupillary response evaluation using a handheld device that measures responses to different colored light stimuli
  3. Have their eye movements analyzed
  4. Have retinal and choroidal thickness, blood perfusion, and ocular oxygen levels measured
  5. Have basic body measurements recorded (such as pulse rate and blood pressure)
  6. Complete tests at multiple time points over 2 hours after consumption

The results of this study may help develop a quick and non-invasive way to detect recent caffeine or alcohol use for clinical and safety purposes.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Caffeine and alcohol are widely consumed psychoactive substances that affect the central and autonomic nervous systems. These effects can influence ocular function, including pupil responses to light, eye movements, and retinal physiology. However, objective and non-invasive methods to detect and differentiate these effects remain limited.

The pupillary light reflex is a sensitive indicator of autonomic nervous system activity. Chromatic pupillometry, which uses different colored light stimuli, allows assessment of specific retinal pathways and provides detailed information about pupil function. This study aims to determine whether changes in pupillary responses and other ocular measurements can be used to detect recent caffeine or alcohol consumption.

Study Design and Procedures A total of 100 healthy adults aged 30-50 years will participate in this study.

Each participant will attend three study visits, corresponding to the following conditions:

  1. Caffeine condition (~3 mg/kg)
  2. Alcohol condition (target blood alcohol concentration ~0.05%)
  3. Placebo condition The order of conditions will be randomized. This is a double-masked, within-subject crossover study, where each participant undergoes all three conditions.

Study Visit Procedures

At each visit, participants will receive one tablet and one beverage according to the assigned condition:

  1. Placebo condition: placebo tablet with a non-alcoholic beverage
  2. Alcohol condition: placebo tablet with an alcohol-containing beverage
  3. Caffeine condition: caffeine tablet with a non-alcoholic beverage Procedures will be standardized to maintain masking, and study personnel performing assessments will remain unaware of the assigned condition.

Assessments All measurements will be performed at baseline (before consumption) and at 30, 60, 90, and 120 minutes after consumption, unless otherwise specified.

  1. Pupillary Assessment: Pupillary responses will be measured using a handheld chromatic pupillometry device in a controlled dark environment. Different colored light stimuli will be used to assess pupil function.
  2. Eye Movement Analysis: Eye movements will be recorded to evaluate oculomotor function, including tracking, fixation, and gaze behavior at baseline, 60 minutes, and 120 minutes.
  3. Retinal and Choroidal Imaging: Retinal and choroidal thickness and blood perfusion will be measured using optical coherence tomography (OCT) and OCT angiography at baseline, 60 minutes, and 120 minutes.
  4. Breath Alcohol Measurement: Breath alcohol concentration will be measured using a breathalyzer at all time points to monitor alcohol levels.
  5. Physiological Measurements: Basic physiological parameters will be recorded, including: Pulse rate, Blood pressure, Blood Oxygen saturation

Data Analysis Data from pupillary responses, eye movements, retinal imaging, and physiological measurements will be combined to identify patterns associated with caffeine and alcohol intake.

Expected Outcomes This study aims to identify measurable changes in pupil responses and other ocular parameters following caffeine and alcohol consumption. It will also evaluate whether a portable, non-invasive system can be used to detect alcohol and caffeine consumption.

The findings may support the development of rapid and objective screening tools for clinical, occupational, and public safety applications.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Vicknaswari T, Bsc Optometry
  • Numero di telefono: +6565165459
  • Email: tv96@nus.edu.sg

Backup dei contatti dello studio

Luoghi di studio

  • Singapore
      • Singapore, Singapore, 119276
        • Reclutamento
        • National University of Singapore, E7 Building, Level 7, 15 Kent Ridge Cres
        • Investigatore principale:
          • Raymond P. Najjar, PhD
        • Contatto:
          • Vicknaswari T, BSc
          • Numero di telefono: +6565165459
          • Email: tv96@nus.edu.sg
        • Contatto:
        • Sub-investigatore:
          • Najiya S.K. Meethal, PhD
        • Sub-investigatore:
          • Catherina Josephine Goenadi, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Participants must meet the inclusion criteria, as shown below, to participate in this study

Inclusion Criteria

  1. Age: 30 to 50 years of age
  2. Visual Acuity: Best Corrected Visual Acuity (BCVA) of 0.20 LogMAR or better in both eyes
  3. Ability to provide informed consent: Participants must be able to understand and sign the informed consent form
  4. Ability to consume both caffeine and alcohol: Participants must be willing and able to consume caffeine and alcohol as part of the study

Participants meeting any of the exclusion criteria, as shown in the table below, will be excluded from participation.

Exclusion Criteria

  1. Diagnosed ocular conditions: Participants with ocular or ocular movement diseases such as glaucoma, age-related macular degeneration, diabetic retinopathy, amblyopia, severe ptosis, or conditions relating to pupils: anisocoria, irregular pupil, Adie tonic, Horner's syndrome, Argyll Robertson pupil, etc. These exclude cataracts, refractive errors, and any ocular condition not affecting vision or ocular movement or obstructing the pupil.
  2. Diagnosed and unresolved neurological conditions:Stroke, unresolved traumatic brain injury, space-occupying lesions in the brain, neuropathies, demyelinating conditions, nerve palsies, etc.
  3. Diagnosed systemic conditions that may restrict the participant from drinking caffeine or alcohol: Hypertension, cardiovascular disease, liver disease, kidney disease, etc.
  4. Medications: Participants taking any medications that may interact with caffeine or alcohol, affect alertness, or cause drowsiness
  5. Previous complex intraocular eye surgery: Participants who have undergone any eye surgery other than uncomplicated refractive surgery.
  6. Pregnancy or breastfeeding: Pregnant or breastfeeding women will be excluded from the study, as caffeine and alcohol can affect the fetus or baby
  7. History of substance abuse: Participants with a history of substance abuse
  8. Allergies or sensitivities: Participants with allergies or sensitivities to caffeine or alcohol
  9. Shift work or having travelled across 2 time zones over the past 2 weeks: This is essential to avoid any impact of sleep deprivation on our outcome measures
  10. Non-consumers or light-consumers of caffeine and alcohol Participants who are light consumers of caffeine or alcohol will be excluded due to higher sensitivity to side effects.

Caffeine: If less than 100 mg of caffeine per week from all sources (including coffee, soft drinks, energy drinks, chocolate, and medications) based on the CCQ* Alcohol: If AUDIT-C** score less than 1

11- Extremely frequent consumers Participants who are extremely frequent consumers of caffeine or alcohol will be excluded due to potential withdrawal symptoms during the required 18-hour abstinence and possible reduced sensitivity to administered doses.

Caffeine: If more than 400mg of caffeine (e.g., 5 espressos) per day from all sources (including coffee, soft drinks, energy drinks, chocolate, and medications) based on the CCQ* Alcohol: If AUDIT-C** scores more than 4 for men and more than 3 for women

Note: Participants will complete a history update questionnaire at each laboratory visit to report any changes relevant to the exclusion criteria. If a participant no longer meets the eligibility criteria at any visit after the baseline assessment, the visit will either be rescheduled, if appropriate, or the participant will be withdrawn from the study. Reimbursement will be provided on a prorated basis.

*CCQ: Caffeine Consumption Questionnaire

**AUDIT-C: Alcohol Use Disorders Identification Test-C

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Participants receive placebo tablets and non-active beverage under double-masked crossover conditions.
Altro: Placebo Comparator: Placebo
Participants receive a matched placebo tablet together with a non-alcoholic beverage identical in appearance and volume to the active conditions. A cornstarch-based formulation may be used for the placebo tablet. Beverage presentation is standardized to maintain blinding across study conditions. No active caffeine or alcohol is administered.
Sperimentale: Caffeine
Participants receive caffeine administration under double-masked crossover conditions.
Altro: Caffeine administration
Participants receive a single oral dose of caffeine (~3 mg/kg body weight) administered in tablet form. The caffeine is given with a non-alcoholic beverage matched to study conditions. All procedures are performed under randomized, double-masked crossover design conditions.
Sperimentale: Alcohol
Participants receive alcohol administration under double-masked crossover conditions.
Altro: Alcohol (Ethanol)
Participants consume a standardized alcoholic beverage designed to achieve a target blood alcohol concentration of approximately 0.05%. A placebo tablet is administered alongside the beverage to maintain masking. All procedures are performed under randomized, double-masked crossover design conditions.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline Pupil Size
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Baseline pupil size will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Baseline pupil size refers to the resting pupil diameter measured prior to light stimulation. It is measured in pixels.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Phasic Pupil Constriction to Blue Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Phasic pupil constriction to blue light will be quantified using handheld chromatic pupillometry. Phasic pupil constriction to blue light refers to the rapid, transient decrease in pupil diameter that occurs immediately after the onset of a blue light stimulus. It is calculated as a percentage change from baseline.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum Pupil Constriction to Blue Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum pupil constriction to blue light will be quantified using handheld chromatic pupillometry. Maximum pupil constriction to blue light refers to the greatest reduction in pupil diameter observed following the onset of a blue light stimulus. It is calculated as a percentage change from baseline.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil Constriction Latency to Blue Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil constriction latency to blue light will be quantified using handheld chromatic pupillometry. Constriction latency is defined as the time from blue light onset to the first detectable decrease in pupil diameter relative to baseline. It is measured in seconds or milliseconds.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Phasic Pupil Constriction to Red Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Phasic pupil constriction to red light will be quantified using handheld chromatic pupillometry. Phasic pupil constriction to red light refers to the rapid, transient decrease in pupil diameter that occurs immediately after the onset of a red light stimulus. It is calculated as a percentage change from baseline.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum Pupil Constriction to Red Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum pupil constriction to red light will be quantified using handheld chromatic pupillometry. Maximum pupil constriction to red light refers to the greatest reduction in pupil diameter observed following the onset of a red light stimulus. It is calculated as a percentage change from baseline.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil Constriction Latency to Red Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil constriction latency to red light will be quantified using handheld chromatic pupillometry. Constriction latency is defined as the time from red light onset to the first detectable decrease in pupil diameter relative to baseline. It is measured in seconds or milliseconds.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Phasic Pupil Constriction to Continuous White Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Phasic pupil constriction to continuous white light will be quantified using handheld chromatic pupillometry. Phasic pupil constriction to white light refers to the rapid, transient decrease in pupil diameter that occurs immediately after the onset of a white light stimulus. It is calculated as a percentage change from baseline.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum Pupil Constriction to Continuous White Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum pupil constriction to continuous white light will be quantified using handheld chromatic pupillometry. Maximum pupil constriction to white light refers to the greatest reduction in pupil diameter observed following the onset of a white light stimulus. It is calculated as a percentage change from baseline.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil Constriction Latency to Continuous White Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil constriction latency to continuous white light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Constriction latency is defined as the time from white light onset to the first detectable decrease in pupil diameter relative to baseline. It is measured in seconds.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum Pupil Constriction to White Light Flash
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Maximum pupil constriction to white light flash will be quantified using using handheld chromatic pupillometry. Maximum pupil constriction to white light refers to the greatest reduction in pupil diameter observed following the onset of a white light stimulus. It is calculated as a percentage change from baseline.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-Stimulus Pupil Recovery Slope to Blue Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-stimulus pupil recovery slope to blue light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Post-stimulus pupil recovery slope refers to the rate of pupil re-dilation following the offset of a blue light stimulus. It is calculated as percentage change per second.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil Slope to Blue Light 1.7s before Blue Light Offset
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil slope to blue light 1.7s before blue light offset will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Pupil slope to blue light within the last 1.7s refers to the rate of pupil re-dilation just before the offset of a blue light stimulus. It is calculated as percentage change per second.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil Slope to Blue Light 1.7s after Blue Light Offset
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pupil slope to blue light in the 1.7s after blue light offset will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Pupil slope to blue light in the 1.7s after blue light offset refers to the rate of pupil re-dilation just after the offset of a blue light stimulus. It is calculated as percentage change per second.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-Stimulus Pupil Recovery Slope to Red Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-stimulus pupil recovery slope to red light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Post-stimulus pupil recovery slope refers to the rate of pupil re-dilation following the offset of a red light stimulus. It is calculated as percentage change per second.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-Stimulus Pupil Recovery Slope to White Light Flash
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-stimulus pupil recovery slope to white light flash will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Post-stimulus pupil recovery slope refers to the rate of pupil re-dilation following the offset of a white light stimulus. It is calculated as percentage change per second.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-Stimulus Pupil Recovery Slope to Continuous White Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-stimulus pupil recovery slope to continuous white light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. Post-stimulus pupil recovery slope refers to the rate of pupil re-dilation following the offset of a white light stimulus. It is calculated as percentage change per second.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
PIPR at 6 s - Blue Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-illumination pupillary responses (PIPR) to blue light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. PIPR refers to the sustained pupil constriction that persists after the termination of a light stimulus. PIPR at 6 s is measured as pupil size at 6 seconds after blue light offset. It is calculated as a percentage of baseline pupil size.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
PIPR at 12 s - Blue Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-illumination pupillary responses (PIPR) to blue light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. PIPR refers to the sustained pupil constriction that persists after the termination of a light stimulus. PIPR at 12 s is measured as pupil size at 12 seconds after blue light offset. It is calculated as a percentage of baseline pupil size.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
PIPR Area Under the Curve (0-12 s) - Blue Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-illumination pupillary responses (PIPR) to blue light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. PIPR refers to the sustained pupil constriction that persists after the termination of a light stimulus. PIPR area under the curve (AUC) from 0 to 12 seconds captures the total magnitude and duration of the sustained post-illumination response. It is calculated as the integrated area in %.s.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
PIPR at 6 s - Red Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-illumination pupillary responses (PIPR) to red light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. PIPR refers to the sustained pupil constriction that persists after the termination of a light stimulus. PIPR at 6 s is measured as pupil size at 6 seconds after red light offset. It is calculated as a percentage of baseline pupil size.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
PIPR Area Under the Curve - Red Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-illumination pupillary responses (PIPR) to red light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. PIPR refers to the sustained pupil constriction that persists after the termination of a light stimulus. PIPR area under the curve (AUC) from 0 to end of recording captures the total magnitude and duration of the sustained post-illumination response. It is calculated as the integrated area in %.s.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
PIPR at 6 s - Flash White Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-illumination pupillary responses (PIPR) to white light flash will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. PIPR refers to the sustained pupil constriction that persists after the termination of a light stimulus. PIPR at 6 s is measured as pupil size at 6 seconds after white light offset. It is calculated as a percentage of baseline pupil size.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
PIPR at 6 s - Continuous White Light
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Post-illumination pupillary responses (PIPR) to continuous white light will be quantified using chromatic pupillometry with a handheld chromatic pupillometer. PIPR refers to the sustained pupil constriction that persists after the termination of a light stimulus. PIPR at 6 s is measured as pupil size at 6 seconds after white light offset. It is calculated as a percentage of baseline pupil size.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Retinal Thickness
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Retinal thickness will be assessed using Triton swept-source optical coherence tomography (SS-OCT). Retinal thickness is defined as the axial distance between the internal limiting membrane and the retinal pigment epithelium, measured in micrometres (µm), and is automatically quantified across the nine ETDRS subfields of the 12 × 9 mm macular volume scan.
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Choroidal Thickness
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Choroidal thickness will be assessed using swept-source optical coherence tomography (SS-OCT). Choroidal thickness is defined as the perpendicular distance between the outer boundary of Bruch's membrane and the chorioscleral interface, measured in micrometres (µm), and is automatically segmented across the nine ETDRS subfields.
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Superficial Capillary Plexus Vessel Density
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Vessel density of the superficial capillary plexus (SCP) will be assessed using optical coherence tomography angiography (OCTA). Using the 6 × 6 mm macular OCTA scan, the SCP is automatically segmented by the built-in IMAGEnet software. Vessel density is defined as the proportion of the measurement area occupied by detected blood flow signals, reported as a percentage (%) across the whole image and individual ETDRS subfields.
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Deep Capillary Plexus Vessel Density
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Vessel density of the deep capillary plexus (DCP) will be assessed using optical coherence tomography angiography (OCTA). Using the 6 × 6 mm macular OCTA scan, the DCP is automatically segmented by the built-in IMAGEnet software. Vessel density is defined as the proportion of the measurement area occupied by detected blood flow signals, reported as a percentage (%) across the whole image and individual ETDRS subfields.
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Choriocapillaris Vessel Density
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Choriocapillaris vessel density will be assessed using optical coherence tomography angiography (OCTA). Using the 6 × 6 mm macular OCTA scan, the choriocapillaris slab is automatically segmented from 0 to 10.4 µm below the outer boundary of Bruch's membrane. Vessel density is defined as the proportion of the measurement area exhibiting detectable flow signal relative to the total sampled area, reported as a percentage (%).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Foveal Avascular Zone Area
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Foveal avascular zone (FAZ) area will be assessed using optical coherence tomography angiography (OCTA). Using the 6 × 6 mm macular OCTA scan, the FAZ is automatically delineated at the level of the superficial capillary plexus by the built-in IMAGEnet software. FAZ area is defined as the area of the capillary-free region centred on the fovea, measured in square millimetres (mm²).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Choroidal Vascularity Index
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
The choroidal vascularity index (CVI) will be derived from the subfoveal horizontal B-scan of the 12 × 9 mm SS-OCT macular scan. The segmented choroidal region, bounded by Bruch's membrane and the chorioscleral interface, is binarised into luminal (vascular) and stromal areas. CVI is calculated as the ratio of luminal choroidal area to total choroidal area, expressed as a percentage (%).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Prosaccade Latency
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Prosaccade latency will be assessed using eye tracking. Prosaccade latency refers to the time interval between the onset of a visual target and the initiation of the corresponding prosaccade eye movement. It is measured in milliseconds (ms).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Prosaccade Peak Velocity
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Prosaccade peak velocity will be assessed using eye tracking. Prosaccade peak velocity refers to the maximum angular velocity achieved during a prosaccade movement. It is measured in degrees per second (°/s).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Prosaccade Amplitude
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Prosaccade amplitude will be assessed using eye tracking. Prosaccade amplitude refers to the total angular displacement of the eye during a prosaccade movement. It is measured in degrees (°).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Smooth Pursuit Gain
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Smooth pursuit gain will be assessed using eye tracking. Smooth pursuit gain refers to the ratio of eye velocity to target velocity during smooth pursuit tracking, where a value of 1.0 indicates perfect tracking. It is expressed as a unitless ratio.
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Catch-Up Saccade Frequency During Smooth Pursuit
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Catch-up saccade frequency will be assessed using eye tracking. Catch-up saccade frequency refers to the number of corrective saccades per second that occur during smooth pursuit tracking, reflecting the degree of pursuit impairment. It is measured as events per second (events/s).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Smooth Pursuit Tracking Accuracy
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Smooth pursuit tracking accuracy will be assessed using eye tracking. Smooth pursuit tracking accuracy refers to the proportion of time the eye position is within an acceptable error window of the pursuit target trajectory. It is calculated as a percentage (%).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Micro-Saccade Rate During Fixation
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Micro-saccade rate will be assessed using eye tracking during a sustained fixation task (30-60 s). Micro-saccade rate refers to the number of micro-saccade events per second during sustained fixation, reflecting fixation stability and cortical arousal. It is measured as events per second (events/s).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Fixation Dispersion
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Fixation dispersion will be assessed using eye tracking during a sustained fixation task (30-60 s). Fixation dispersion refers to the angular spread of gaze position around the fixation target during sustained fixation, quantifying the spatial extent of fixation instability. It is measured in degrees (°).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Fixation Duration During Free Viewing
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Fixation duration during free viewing will be assessed using eye tracking. Fixation duration refers to the mean duration of individual fixations during free viewing of a standardised stimulus, reflecting attentional dwell time. It is measured in milliseconds (ms).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Scanpath Variability During Free Viewing
Lasso di tempo: Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Scanpath variability during free viewing will be assessed using eye tracking. Scanpath variability refers to the angular variability of the gaze trajectory during free viewing, characterising the spread and consistency of spontaneous viewing patterns. It is measured in degrees (°).
Baseline (pre-intervention), 60 and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Breath Alcohol Concentration
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Breath alcohol concentration (BrAC) will be measured using a handheld breathalyzer. BrAC refers to the ethanol concentration in exhaled breath, converted to estimated blood alcohol concentration (BAC) using a standard 1:2100 partition ratio. A target BAC of 0.04-0.06% corresponds to an approximate BrAC of 0.04-0.06 mg/210L. It is measured in mg/210L.
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Peripheral Oxygen Saturation (SpO₂)
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter. SpO₂ refers to the estimated percentage of oxyhaemoglobin relative to total haemoglobin in peripheral blood, providing a non-invasive measure of systemic oxygenation. It is measured as a percentage (%).
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pulse Rate
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Pulse rate will be measured using automated sphygmomanometry. Pulse rate refers to the number of arterial pulsations per minute, reflecting heart rate and cardiovascular autonomic response to intervention. It is measured in beats per minute (bpm).
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Systolic Blood Pressure
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Systolic blood pressure will be measured using automated sphygmomanometry. Systolic blood pressure refers to the peak arterial pressure during cardiac contraction, reflecting cardiovascular autonomic response to intervention. It is measured in millimetres of mercury (mmHg).
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Diastolic Blood Pressure
Lasso di tempo: Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Diastolic blood pressure will be measured using automated sphygmomanometry. Diastolic blood pressure refers to the minimum arterial pressure during cardiac relaxation, reflecting cardiovascular autonomic response to intervention. It is measured in millimetres of mercury (mmHg).
Baseline (pre-intervention), 30, 60, 90, and 120 minutes post-intervention - during each of the 3 study visits (up to 3 study days total)
Weight
Lasso di tempo: Baseline (pre-intervention) during each of the 3 study visits (up to 3 study days total)
Weight of participant in kilograms
Baseline (pre-intervention) during each of the 3 study visits (up to 3 study days total)
Height
Lasso di tempo: Baseline (pre-intervention) during each of the 3 study visits (up to 3 study days total)
Height of the participant in meters
Baseline (pre-intervention) during each of the 3 study visits (up to 3 study days total)
Body Mass Index (BMI)
Lasso di tempo: Calculated at baseline (pre-intervention) during each of the 3 study visits (up to 3 study days total)
Calculated as participant's weight in kilograms divided by the square of participant's height in meters (kg/m^2).
Calculated at baseline (pre-intervention) during each of the 3 study visits (up to 3 study days total)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National University of Singapore

Collaboratori

Home Team Science & Technology Agency (HTX)

Investigatori

  • Investigatore principale: Raymond P. Najjar, PhD, Department of Ophthalmology, National University of Singapore (NUS)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

5 maggio 2027

Completamento dello studio (Stimato)

5 novembre 2027

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NUS-IRB-2025-1150

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Individual participant data (IPD) may not be shared due to participant confidentiality, privacy protection, and compliance with institutional or sponsor and regulatory data governance policies.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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