NCT02014389

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2013Dec 2026

Study Start

First participant enrolled

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

13.1 years

First QC Date

December 12, 2013

Last Update Submit

April 24, 2024

Conditions

Keywords

Retinal DystrophiesRetinitis PigmentosaGlaucomaVisual Field

Outcome Measures

Primary Outcomes (1)

  • PLR response amplitude and latency

    single visit

Study Arms (2)

Healthy subjects

Healthy subjects will be used as control group

Patients

Patients with Glaucoma , Patients with retinal dystrophy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Cloudy corneas.
  • Surgical intraocular ophthalmic procedure within the past 30 days.
  • No reactive pupils.
  • Synechia of the iris to the lens after surgery or inflammation.
  • Neovascularization.
  • Axenfeld-Rieger Syndrome.
  • Iris atrophy (ICE syndrome).
  • Iris coloboma.
  • Sphincter damage due to ischemia.
  • Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).
  • Sphincter damage due to Herpes Zoster Uveitis.
  • Sphincter damage due to high intraocular pressure.
  • Iris tumor or cyst.
  • Ectropion uvae.
  • Adie's pupil.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Publications (1)

  • Skaat A, Sher I, Kolker A, Elyasiv S, Rosenfeld E, Mhajna M, Melamed S, Belkin M, Rotenstreich Y. Pupillometer-based objective chromatic perimetry in normal eyes and patients with retinal photoreceptor dystrophies. Invest Ophthalmol Vis Sci. 2013 Apr 17;54(4):2761-70. doi: 10.1167/iovs.12-11127.

    PMID: 23482470BACKGROUND

MeSH Terms

Conditions

Retinal DystrophiesRetinitis PigmentosaGlaucoma

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOcular Hypertension

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Electrophisiology Unit, Maurice and Gabriela Goldschleger Eye Research Institute

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 18, 2013

Study Start

December 1, 2013

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations