Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

January 15, 2023 updated by: Dr. Ygal Rotenstreich, Sheba Medical Center

Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients

Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Pupil light reflex (PLR) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field.

A computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 LEDs, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Two Groups: 1. Control, 2. Patients - Glaucoma patients with early damage (nasal step) of Humphrey visual field (HVF), Glaucoma patients with advanced damage of HVF (arcuate , tubular vision) and retinal dystrophy patientsl

Description

Inclusion Criteria:

  • Age 18-80 years old.
  • Signing informed consent.
  • Pupillary reflex to light.

Exclusion Criteria:

  1. Cloudy corneas.
  2. Surgical intraocular ophthalmic procedure within the past 30 days.
  3. No reactive pupils.
  4. Synechia of the iris to the lens after surgery or inflammation.
  5. Neovascularization.
  6. Axenfeld-Rieger Syndrome.
  7. Iris atrophy (ICE syndrome).
  8. Iris coloboma.
  9. Sphincter damage due to ischemia.
  10. Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).
  11. Sphincter damage due to Herpes Zoster Uveitis.
  12. Sphincter damage due to high intraocular pressure.
  13. Iris tumor or cyst.
  14. Ectropion uvae.
  15. Adie's pupil.
  16. Third nerve aberrant regeneration of the iris sphincter.
  17. RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect).
  18. Chronic use of myotics or mydriatics.
  19. Systemic medication that have affect on pupillary reflex .
  20. Any condition preventing accurate measurement or examination of the pupil.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort
Healthy subjects
Healthy subjects will be used as control group
Patients
Patients with Glaucoma , Patients with retinal dystrophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PLR response amplitude and latency
Time Frame: single visit
single visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 18, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA -13 -0640-YR-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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