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Trial record 49 of 145 for:    "Retinitis pigmentosa"

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

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ClinicalTrials.gov Identifier: NCT03322930
Recruitment Status : Enrolling by invitation
First Posted : October 26, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Retina Foundation of the Southwest

Brief Summary:
A new fundus-guided microperimeter, the 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.

Condition or disease Intervention/treatment
Retinitis Pigmentosa AMD Diagnostic Test: Rod sensitivity

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
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019


Group/Cohort Intervention/treatment
RP
patients with a diagnosis of retinitis pigmentosa
Diagnostic Test: Rod sensitivity
diagnostic test for rod loss in central retina

AMD
patients with a diagnosis of intermediate AMD
Diagnostic Test: Rod sensitivity
diagnostic test for rod loss in central retina




Primary Outcome Measures :
  1. Rod sensitivity within the central retina as measured on the Nidek MP-3S [ Time Frame: 2 years ]
    Rod sensitivity measured in decibels at multiple retinal locations within the central retina



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Ages Eligible for Study:   10 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

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): NCT03322930


Locations
United States, Texas
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Retina Foundation of the Southwest
Investigators
Principal Investigator: David G Birch, PhD Retina Foundation of the Southwest

Additional Information:
Responsible Party: Retina Foundation of the Southwest
ClinicalTrials.gov Identifier: NCT03322930     History of Changes
Other Study ID Numbers: STU082017-084
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: anonymized rod visual fields

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Retina Foundation of the Southwest:
microperimetry
rod visual fields

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