Retinitis PigmentosaNCT03322930
Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
An observational study of Retinitis Pigmentosa and AMD, run by Retina Foundation of the Southwest at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa, AMD
- What is being tested?
- Rod sensitivity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Mar 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- clear media
- diagnosis of RP or non neovascular AMD
- normal volunteers
Who cannot join
- exudative AMD
- other eye diseases that could cause vision loss
- physical ailments that would preclude comfortable testing
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Foundation of the Southwest
Dallas, Texas, 75231
About this study
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.
Read the 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.
- Conditions
- Retinitis Pigmentosa, AMD
- Being tested
- Rod sensitivity
- Keywords
- microperimetry, rod visual fields
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rod sensitivityDiagnostic test
diagnostic test for rod loss in central retina
| Study group | Role | What they receive |
|---|---|---|
| Retinitis Pigmentosa | patients with a diagnosis of retinitis pigmentosa and reduced rod function on baseline testing Receives: Diagnostic Test: Rod sensitivity | |
| Age-related Macular Degeneration | patients with a diagnosis of intermediate AMD and reduced rod function on baseline testing Receives: Diagnostic Test: Rod sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Foundation of the Southwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David G Birch, PhD, Principal investigator, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322930
- Sponsor's protocol ID
- STU082017-084
- Status last verified
- Dec 2019
- First submitted
- 24 Oct 2017
- Last updated
- 23 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymized rod visual fields
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
- ClinicalTrials.gov ID
- NCT03322930
- Acronym / sponsor ID
- STU082017-084
- Conditions
- Retinitis Pigmentosa, AMD
- Keywords
- microperimetry, rod visual fields
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Posted 4 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retinitis Pigmentosa | – | Diagnostic Test: Rod sensitivitypatients with a diagnosis of retinitis pigmentosa and reduced rod function on baseline testing |
| Age-related Macular Degeneration | – | Diagnostic Test: Rod sensitivitypatients with a diagnosis of intermediate AMD and reduced rod function on baseline testing |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- clear media
- diagnosis of RP or non neovascular AMD
- normal volunteers
Key exclusion criteria (4 listed)
- exudative AMD
- other eye diseases that could cause vision loss
- physical ailments that would preclude comfortable testing
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rod sensitivitydiagnostic test for rod loss in central retina | Diagnostic test | Age-related Macular Degeneration, Retinitis Pigmentosa |
Primary outcome
Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S
Time frame: through study completion, an average of 1 year
Number of participants with rod sensitivity measured in decibels at multiple retinal locations within the central retina
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Retina Foundation of the Southwest websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. anonymized rod visual fields
Related trials for Retinitis Pigmentosa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Birch, PhD principal investigator
Retina Foundation of the Southwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa and AMD, run by Retina Foundation of the Southwest at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.