- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322930
Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
December 11, 2019 updated by: Retina Foundation of the Southwest
A new fundus-guided microperimeter (MP-3S) has been developed by Nidek, Inc. to track the fundus of the patient and present stimuli in specific anatomically-defined locations.
Furthermore, this tracking means that exactly the same locations can be tested on subsequent (follow-up) visits.
The investigators will use a method called two-color perimetry to map rod and cone sensitivity on this device.
With this technique, the sensitivity difference (blue-red) to chromatic test stimuli can be used to determine whether rods, cones or both photoreceptor systems mediate the threshold at a given location in the macula.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Despite recent advances in understanding the pathogenesis of retinitis pigmentosa (RP) and age-related macular degeneration (AMD), precise characterization of the disease phenotype remains elusive.
In both diseases, much of the focus has necessarily been on the loss of cone function, since visual fields, acuity and contrast sensitivity are typically measured under photopic conditions.
In RP, we need a greater understanding of patterns of rod loss since most disease-causing mutations affect primarily rods.
In AMD, recent findings have shown that scotopic sensitivity can be much more affected than conventional photopic measurements such as visual acuity.
For patients, however, it is difficult to maintain stable fixation, especially when central vision is compromised.
A new fundus-guided microperimeter, the MP-3S, has been developed by Nidek, Inc. to circumvent this problem.
The investigators will evaluate the value of this device for following rod and cone loss in patients with either RP or AMD.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75231
- Retina Foundation of the Southwest
-
-
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
10 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
50 subjects with retinitis pigmentosa 50 patients with AMD 10 normal volunteers ages 18 to 40 and 10 normal volunteers ages over age 55 years
Description
Inclusion Criteria:
- clear media
- diagnosis of RP or non neovascular AMD
- normal volunteers
Exclusion Criteria:
- exudative AMD
- other eye diseases that could cause vision loss
- physical ailments that would preclude comfortable testing
- unable to provide informed consent
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Retinitis Pigmentosa
patients with a diagnosis of retinitis pigmentosa and reduced rod function on baseline testing
|
diagnostic test for rod loss in central retina
|
Age-related Macular Degeneration
patients with a diagnosis of intermediate AMD and reduced rod function on baseline testing
|
diagnostic test for rod loss in central retina
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S
Time Frame: through study completion, an average of 1 year
|
Number of participants with rod sensitivity measured in decibels at multiple retinal locations within the central retina
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David G Birch, PhD, Retina Foundation of the Southwest
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.
Helpful Links
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 (Actual)
October 1, 2017
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
December 23, 2019
Last Update Submitted That Met QC Criteria
December 11, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU082017-084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
anonymized rod visual fields
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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