Rod and Cone Mediated Function in Retinal Disease

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT02617966

Collaborator

(none)

370

Enrollment

Location

105.2

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness. Researchers want to learn about rod and cone function in healthy people and people with retinal disease. They want to know if how well a person sees in the dark can test the severity of retinal disease.

Objectives:

To find out if how well a person sees in the dark can test the severity of retinal disease. To find out if this can help detect retinal disease and track its changes.

Eligibility:

People ages 5 and older with:

Retinal disease OR

20/20 vision or better with or without correction in at least one eye

Design:

Participants will be screened with medical and eye history and eye exam. Those with retinal disease will also have:

Eye imaging: Drops dilate the eye and pictures are taken of it.

Visual field testing: Participants look into a bowl and press a button when they see light.

Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the

dark with their eyes patched for 30 minutes. Then they get numbing drops and contact

lenses. Participants watch lights while retina signals are recorded.

Visit 1 will be 3-8 hours. Participants will have up to 6 more visits over 6-12 months.

Visits include:

Eye exam and imaging

Time course of dark adaptation: Participants view a background light for 5 minutes then

push a button when they see colored light.

Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button when

they see colored light.

For participants with retinal disease, ERG and visual field testing

Condition or Disease	Intervention/Treatment	Phase
Retinal Degeneration Retinitis Pigmentosa Stargardt's Disease

Detailed Description

Objective: The objective of this protocol is to investigate local changes in rod and cone photoreceptor function across the retina in healthy volunteers and participants with retinal disease.

Study Population: Up to 120 healthy volunteers and 250 participants, age five or older, with retinal disease.

Design: This single-center, observational, case-control study will be comprised of three related Aims that assess rod and cone function with the recently released commercial Medmont Dark Adapted Chromatic (DAC) perimeter and/or a commercial Cambridge Research Systems computer monitor (Display++) specialized for displaying stimuli at low light intensities. and/or the scotopic MP1S perimeter.

For Aim 1 the normal ranges will be established for dark-adapted retinal sensitivities to blue and red stimuli of the DAC perimeter, and MP1S perimeter, and for radial frequency (RF) hyperacuity on the Display++ monitor. For Aim 2, the normal range will be established for describing the kinetics of dark adaptation following bleaching of retinal rhodopsin for the DAC and MP1S perimeters. For Aim 3, local changes in rod and cone photoreceptor function across the retina in participants with retinal disease will be examined from measurement of the kinetics of dark adaptation, dark-adapted retinal sensitivity to the DAC blue and red stimuli, and/or RF hyperacuity on the Display++ monitor, and/or the MP1S perimeter.

Outcome Measures: The primary outcome for this study is to establish normal ranges for A) the kinetics of dark adaptation (time), B) dark adapted retinal sensitivity (dB) for the Medmont DAC and MP1S blue and red stimuli, and C) RF hyperacuity on the Display++ monitor. The secondary outcomes will be to examine changes in the kinetics of dark adaptation, dark adapted retinal sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease.

Study Design

Study Type:

Observational

Anticipated Enrollment :

370 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Rod and Cone Mediated Function in Retinal Disease

Actual Study Start Date :

Mar 24, 2016

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Affected Participants with retinal disease
Unaffected Healthy volunteers

Outcome Measures

Primary Outcome Measures

The primary outcomes for this study are to establish normal ranges for the kinetics of dark adaptation and dark-adapted retinal sensitivity for the fundus guided and non-guided perimeters and for RF hyperacuity on the Display++. [ongoing, up to 10 visits in 5 years]
The primary outcomes for this study are to establish normal ranges for the kinetics of dark adaptation and dark-adapted retinal sensitivity for the fundus guided and non-guided perimeters and for RF hyperacuity on the Display++.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:
Participant must be 5 years of age or older.
Participant (or legal guardian) must understand and sign the protocol s informed consent document.
Participant must be able to cooperate with the testing required for this study.

For Participants with retinal disease only:

Participant must have retinal disease, defined as evidence of loss of retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging.
Participant must have a measurable visual acuity.