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Trial record 14 of 337 for:    "Eye Diseases, Hereditary" OR "Lenz microphthalmia syndrome"

Rod and Cone Mediated Function in Retinal Disease

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ClinicalTrials.gov Identifier: NCT02617966
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

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
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. For Aim 1 the normal ranges will be established for dark-adapted retinal sensitivities to blue and red stimuli of the DAC 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 perimeter. 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.

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 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 Type : Observational
Estimated Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rod and Cone Mediated Function in Retinal Disease
Study Start Date : November 28, 2015
Estimated Primary Completion Date : August 24, 2020
Estimated Study Completion Date : August 24, 2020





Primary Outcome Measures :
  1. 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 blue and red stimuli, and C) RF hyperacuity on the Display++ monitor. [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Ongoing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

For Healthy Volunteers only:

-Participant must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens) in at least one eye.

EXCLUSION CRITERIA:

-Participant with changes in pre-retinal media sufficient to obscure a view of the retina.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617966


Contacts
Contact: Daniel W Claus, R.N. (301) 496-9058 daniel.claus@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Principal Investigator: Brett G Jeffrey, Ph.D. National Eye Institute (NEI)

Additional Information:
Publications:
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT02617966     History of Changes
Other Study ID Numbers: 160024
16-EI-0024
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: April 16, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Retina
Retinal Degeneration
Retinitis Pigmentosa
Stargardt's Disease
Dark Adaptation

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Retinal Degeneration
Macular Degeneration
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn