Status:

COMPLETED

Pupil Dynamics and Color Vision for the Detection of Eye Diseases

Lead Sponsor:

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Collaborating Sponsors:

Streetlab

Conditions:

Retinitis Pigmentosa

Leber's Hereditary Optic Neuropathy

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice. The preliminary results obtained with innovative devices ...

Detailed Description

This is a single-head study that will take place at the National Ophthalmology Hospital Center (CHNO) and the Vision Institute (Streetlab) and the total duration of the study is 24 months . It is pla...

Eligibility Criteria

Inclusion

  • \- Patients with an understanding of the French language to ensure a perfect understanding of the instructions during evaluations and documents relating to their involvement in the study.
  • Visually impaired volunteers:
  • Patients must have one of three conditions: Retinitis Pigmentosa, Stargardt disease, Leber optic neuropathy.
  • Healthy volunteers:
  • Visual acuity of both corrected eyes (glasses) should be higher or equal 8/10th and a normal visual field.
  • Patients should not wear contact lenses (which may interfere with the recording of the pupil and eye movements)

Exclusion

  • Pregnant or lactating women will not be able to participate in this research.
  • Participants should not be unable to personally consent.
  • Subjects should not participate in another clinical trial that may interfere with this research.
  • Inability to personally consent.
  • Subjects should not present with degenerative diseases or any other disease that could interfere with the evaluations planned during this study.
  • The subject follows a drug treatment which can cause visual disturbances, changes in pupillary kinetics or cognitive disturbances.
  • Secondary exclusion criteria (at the end of the inclusion visit):
  • Visually impaired subjects and controls for which calibration is not feasible.
  • Patients and control subjects having difficulty maintaining visual fixation.
  • Patients and subjects wearing corrective lenses making it impossible to record oculomotor activity with an infrared camera oculometer.

Key Trial Info

Start Date :

March 22 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 22 2019

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04909398

Start Date

March 22 2018

End Date

May 22 2019

Last Update

June 1 2021

Active Locations (1)

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Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts

Paris, France, 75012