Bulbicam Validation on Glaucoma- and Cataract Patients

Validation of Bulbicam for Use on Patient Suffering From Glaucoma (GLA) and Cataract (CAT)

The aim is to investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from Glaucoma (GLA), b) Cataract (CAT) and matched healthy controls (HC).

The study population consists of the three subpopulations: 1) Patients suffering from GLA; 2) Patients suffering from CAT and 3) Gender- and age-matched HC without any eye diseases.

Bulbicam will be used in the study including six tests and the standard method will be used initially for measurements of "Visual Field" and "Pupil"

The study will be performed as a controlled, open, and non-randomized, stratified observational single center study. The stratification factors will be pathology and the degree of disease. Within each of the four strata, healthy matched controls related to gender and age (1:1) will be included.

The main variables will be the variables recorded at the six Bulbicam and the supporting variables will be recorded by the Standard (ST) investigation. The central variables related to Glaucoma will be the GAT and iCare pressure, "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen", X- and Y-coordinates and "Pupil diameter in mm".

The central variables related to cataract will be "Pupil diameter", "OCT RNFL ", "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen" and the X- and Y-coordinates.

Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening.

Sixteen GLA-patients and 16 CAT-patients equally divided into two substrata will be recruited from the two participating hospitals. For each included patient, one gender- and age-matched HC will be recruited. In total 16 GLA-patients with 16 HC and 16 CAT-patients with 16 HC will be included in the study.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Glaucoma Eye
• Intervention / Treatment: Device: Bulbicam

Detailed Description

Aim

• To investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from a) Glaucoma (GLA), b) Cataract (CAT) and matched healthy controls (HC).
• To compare Bulbicam and the standard method on measurements of Visual field and Pupil
• To contribute to establishment of normal range for GLA and CAT patients with different degrees in the disease development related to the Bulbicam tests.
• To contribute to establishment of normal range for a normal population without eye-disease related to the Bulbicam tests. Study population consists of the following three study populations: 1) Patients suffering from GLA of both genders above 18 years of age with different disease degree; 2) Patients suffering from CAT of both genders above 18 years of age with different disease degree; 3) Gender- and age-matched HC without any eye diseases.

Trial equipment: Bulbicam will be used in the study and the following six tests will be performed at each investigation: "Visual Field", "Ptosis", Dynamic Acuity", "Dynamic Contrast ", "Dark Adaption" and "Pupil". The standard method will be used initially for measurements of "Visual Field" and "Pupil"

Design:

The study will be performed as a controlled, open, and non-randomized, stratified observational single center study. The stratification factors will be pathology (GLA&CAT) and the degree of disease. Within each of the four strata, healthy matched controls related to gender and age (1:1) will be included. The degree of GLA is defined as follows:

1. Mild glaucoma
2. Moderate glaucoma
3. Severe glaucoma

The degree of CAT is defined as follows:

1. Cataract Nuclear Sclerosis - Grade 1
2. Cataract Nuclear Sclerosis - Grade 2

Higher grade cataracts are difficult to have occurred in Norway and thus excluded from this study.

For each included patient, a gender- and age-matched HV will be included. All included participants will perform Bulbicam eye-investigation twice at three flowing days with a rest period of at least one hour. Each investigation includes same six Bulbicam tests. The Standard method will only be performed once as the first investigation at day 1 for measurements of "Visual Field" and "Pupil".

Main variables will be the variables recorded at the six Bulbicam tests. Supporting Variables will be recorded by the Standard (ST) investigation for Glaucoma and Cataract.

The central variables related to Glaucoma will be the GAT and iCare pressure, "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen", X- and Y-coordinates and "Pupil diameter in mm". The central variables related to cataract will be "Pupil diameter", "OCT RNFL ", "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen" and the X- and Y-coordinates.

Study procedure:

Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.

Sample size:

Sixteen GLA-patients and 16 CAT-patients equally divided into two substrata will be recruited from the two participating hospitals. For each included patient, one gender- and age-matched HC will be recruited. In total 16 GLA-patients with 16 HC and 16 CAT-patients with 16 HC will be included in the study. All together the study will include 64 participants.

• Study Type: Observational
• Enrollment (Anticipated): 64

Contacts and Locations

• Study Contact: Name: Stig E Larsen, PhD; Phone Number: 41326325; Email: sl@meddoc.no
• Study Contact Backup: Name: Bård E Dalhoi, MS; Phone Number: 90990199; Email: bard@bulbicam.com

Study Locations

• Norway
  • Viken
    • Skjetten, Viken, Norway, 2013
      • Recruiting
      • Meddoc
      • Contact: Stig E Larsen, PhD; Phone Number: +4741326325; Email: sl@meddoc.no
      • Contact: Bård E Dalhøi, MS; Phone Number: +4790990199; Email: bard@bulbitech.com
      • Principal Investigator: Goran Pertrovski, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study consists of the following three study populations: 1) Patients suffering from GLA of both genders above 18 years of age with different disease degree; 2) Patients suffering from CAT of both genders above 18 years of age with different disease degree; 3) Gender- and age-matched HC without any eye diseases.

Description

Inclusion Criteria:

• Patients diagnosed with either Glaucoma or Cataract of both gender
• Passed the age of 18 years
• Without any other eye disease

Exclusion Criteria:

• Other visual disturbances and blindness
• Posterior Chamber Intraocular Lens (PCIOL)
• Physical or psychiatric disease, which may disturb the measuring procedure
• Patients who are not able to perform eye movements, so no full paresis of any ocular muscles
• Patients whose visual acuity is less than 0.1 in any eye, as these will not be able to focus on the test stimuli.
• Patients whose visible part of the eye is abnormal, such as subconjunctival hemorrhages or deformed pupils
• Patients whose pupils are not able to respond normally to dilation or contraction due to damaged nerves, mechanical damage of the pupil etc.
• With known alcoholic and drug dependency
• Not able to understand information.
• Not willing to give written consent to participate in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glaucoma patients; Patients diagnosed with Glaucoma of both gender; passed the age of 18 years; without any other eye disease; suffering from other know serious disease but have a health situation in accordance with expectations related to the age.	Device: Bulbicam; Measurement of eye pressure; Accuracy diagram; Contrast chart; Visual field, Pupil size; Other Names: Standard eye examination devices
Glaucoma controlls; Gender- and age-matched controls to the Glaucoma patients, passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.	Device: Bulbicam; Measurement of eye pressure; Accuracy diagram; Contrast chart; Visual field, Pupil size; Other Names: Standard eye examination devices
Cateract patients; Patients diagnosed with Cataract of both gender; passed the age of 18 years; without any other eye disease; suffering from other know serious disease but have a health situation in accordance with expectations related to the age.	Device: Bulbicam; Measurement of eye pressure; Accuracy diagram; Contrast chart; Visual field, Pupil size; Other Names: Standard eye examination devices
Cataract controlls; Gender- and age-matched controls to the Cataract patients, passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.	Device: Bulbicam; Measurement of eye pressure; Accuracy diagram; Contrast chart; Visual field, Pupil size; Other Names: Standard eye examination devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAT	Measurement of eye-pressure in mmHg	0 hour
GAT	Measurement of eye-pressure in mmHg	1 hour
GAT	Measurement of eye-pressure in mmHg	24 hours
GAT	Measurement of eye-pressure in mmHg	25 hours
GAT	Measurement of eye-pressure in mmHg	36 hours
GAT	Measurement of eye-pressure in mmHg	37 hours
Visual Field	Saccadic Reaction Time in ms	0 hour
Visual Field	Saccadic Reaction Time in ms	1 hour
Visual Field	Saccadic Reaction Time in ms	24 hours
Visual Field	Saccadic Reaction Time in ms	25 hours
Visual Field	Saccadic Reaction Time in ms	36 hours
Visual Field	Saccadic Reaction Time in ms	37 hours
Ptosis	MDR in mm	0 hour
Ptosis	MDR in mm	1 hour
Ptosis	MDR in mm	24 hours
Ptosis	MDR in mm	25 hours
Ptosis	MDR in mm	36 hours
Ptosis	MDR in mm	37 hours
Dynamic Acuity	Vision acuity in LogMar	0 hour
Dynamic Acuity	Vision acuity in LogMar	1 hour
Dynamic Acuity	Vision acuity in LogMar	24 hours
Dynamic Acuity	Vision acuity in LogMar	25 hours
Dynamic Acuity	Vision acuity in LogMar	36 hours
Dynamic Acuity	Vision acuity in LogMar	37 hours
Dynamic Contrast	Contrast sensitivity in LogCon	0 hour
Dynamic Contrast	Contrast sensitivity in LogCon	1 hour
Dynamic Contrast	Contrast sensitivity in LogCon	24 hours
Dynamic Contrast	Contrast sensitivity in LogCon	25 hours
Dynamic Contrast	Contrast sensitivity in LogCon	36 hours
Dynamic Contrast	Contrast sensitivity in LogCon	37 hours
Dark Adaptation	Fixed contrast; variable frequency in Hz	0 hour
Dark Adaptation	Fixed contrast; variable frequency in Hz	1 hour
Dark Adaptation	Fixed contrast; variable frequency in Hz	24 hours
Dark Adaptation	Fixed contrast; variable frequency in Hz	25 hours
Dark Adaptation	Fixed contrast; variable frequency in Hz	36 hours
Dark Adaptation	Fixed contrast; variable frequency in Hz	37 hours
Pupil	Diameter (mm)	0 hour
Pupil	Diameter (mm)	1 hour
Pupil	Diameter (mm)	24 hours
Pupil	Diameter (mm)	25 hours
Pupil	Diameter (mm)	36 hours
Pupil	Diameter (mm)	37 hours

Collaborators and Investigators

• Sponsor: Meddoc
• Investigators: Study Chair: Goran Petrovski, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Bulbicam
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Cataract
• Other Study ID Numbers: V2_OTH/GLA;CAT-I/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No