Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)

Retinitis Pigmentosa Clinical Trial

Official title:

Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322930
• Other study ID #: STU082017-084
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2019
• Source: Retina Foundation of the Southwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• AMD
• Macular Degeneration
• Retinitis
• Retinitis Pigmentosa

Intervention

Diagnostic Test:
• Rod sensitivity
diagnostic test for rod loss in central retina

Locations

Country	Name	City	State
United States	Retina Foundation of the Southwest	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Retina Foundation of the Southwest

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Retina Foundation of the Southwest website