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

NCT ID: NCT03322930

Last Updated: 2019-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Retinitis Pigmentosa AMD

Keywords

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microperimetry rod visual fields

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Retinitis Pigmentosa

patients with a diagnosis of retinitis pigmentosa and reduced rod function on baseline testing

Rod sensitivity

Intervention Type DIAGNOSTIC_TEST

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

Rod sensitivity

Intervention Type DIAGNOSTIC_TEST

diagnostic test for rod loss in central retina

Interventions

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Rod sensitivity

diagnostic test for rod loss in central retina

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Retina Foundation of the Southwest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David G Birch, PhD

Role: PRINCIPAL_INVESTIGATOR

Retina Foundation of the Southwest

Locations

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Retina Foundation of the Southwest

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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http://retinafoundation.org

Retina Foundation of the Southwest website

Other Identifiers

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STU082017-084

Identifier Type: -

Identifier Source: org_study_id