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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rod sensitivity | Diagnostic Test | diagnostic test for rod loss in central retina |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| David G Birch, PhD | Retina Foundation of the Southwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
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| Label | URL |
|---|---|
| Retina Foundation of the Southwest website | View source |
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anonymized rod visual fields
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patients recruited from medical clinic (Texas Retina Associates)
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With a Diagnosis of Retinitis Pigmentosa | patients with a diagnosis of retinitis pigmentosa Rod sensitivity: diagnostic test for rod loss in central retina |
| FG001 | Patients With Intermediate Age-related Macular Degeneration | patients with a diagnosis of intermediate AMD Rod sensitivity: diagnostic test for rod loss in central retina |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With a Diagnosis of Retinitis Pigmentosa | patients with a diagnosis of retinitis pigmentosa Rod sensitivity: diagnostic test for rod loss in central retina |
| BG001 | Patients With a Diagnosis of Intermediate AMD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With a Diagnosis of Retinitis Pigmentosa | patients with a diagnosis of retinitis pigmentosa Rod sensitivity: diagnostic test for rod loss in central retina |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Birch | Retina Foundation of the Southwest | 214-363-3911 | 105 | dbirch@retinafoundation.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2018 | Nov 14, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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patients with a diagnosis of intermediate AMD
Rod sensitivity: diagnostic test for rod loss in central retina
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Patients With a Diagnosis of Intermediate AMD | patients with a diagnosis of intermediate AMD Rod sensitivity: diagnostic test for rod loss in central retina | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |