Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
1 other identifier
observational
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
December 4, 2019
CompletedDecember 23, 2019
December 1, 2019
1.4 years
October 24, 2017
October 24, 2019
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S
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
Study Arms (2)
Retinitis Pigmentosa
patients with a diagnosis of retinitis pigmentosa and reduced rod function on baseline testing
Age-related Macular Degeneration
patients with a diagnosis of intermediate AMD and reduced rod function on baseline testing
Interventions
diagnostic test for rod loss in central retina
Eligibility Criteria
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
You may qualify if:
- clear media
- diagnosis of RP or non neovascular AMD
- normal volunteers
You may not qualify if:
- exudative AMD
- other eye diseases that could cause vision loss
- physical ailments that would preclude comfortable testing
- unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Birch
- Organization
- Retina Foundation of the Southwest
Study Officials
- PRINCIPAL INVESTIGATOR
David G Birch, PhD
Retina Foundation of the Southwest
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 26, 2017
Study Start
October 1, 2017
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
December 23, 2019
Results First Posted
December 4, 2019
Record last verified: 2019-12