Retinitis PigmentosaNCT05820100
Observational Study to Assess the Reliability and Validity of the MLYMT and MLSDT
An observational study of Retinitis Pigmentosa and Retinal Dystrophy, run by Nanoscope Therapeutics Inc. at 8 sites in 2 countries.
Trial summary
This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Study (MLSDT) Main Outcome Measures: (i) Performance scores in normal and severely visually impaired subjects with a clinical diagnosis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa, Retinal Dystrophy
- What is being tested?
- Observational
- How many people
- 35 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 25 Apr 2023to 17 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll approximately 35 adult subjects, to one of 2 cohorts. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.
Who may be able to join
- Age ≥ 18 years
- Able to comprehend and give informed consent.
- Able to comply with testing and all protocol tests.
- Eligible for 1 of 2 cohorts listed below:
- Cohort 1: Normally Sighted Participants with clinically normal ocular findings and BCVA better than logMAR 0.3 (as confirmed by ETDRS letter score > 73) in each eye Cohort 2: Severely Sight Impaired Participants with BCVA no better than logMAR 1.6 in better seeing eye, and worse than LogMAR 1.9 in the worse seeing eye, and a clinical diagnosis of advanced RP
Who cannot join
- Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months
- Presence of any condition other than RP Disease that impairs visual acuity or visual fields e.g., visually significant cataract or visual field loss in glaucoma
- Presence of neurological condition that impairs visual acuity or visual field, e.g., hemianopia secondary to stroke
- Individuals who refuse or are incapable of performing mobility testing
- Individuals with retinal prosthesis (such as ARGUS-II)
- Participation in Nanoscope studies NTXMCO-002 (RESTORE) or NTXMCO-004 (STARLIGHT)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Nanoscope Clinical Site
Bellaire, Texas, 77401
Nanoscope Clinical Site
Beverly Hills, California, 90211
Nanoscope Clinical Site
Fargo, North Dakota, 58103
Nanoscope Clinical Site
McAllen, Texas, 78503
Nanoscope Clinical Site
Miami, Florida, 33136
Nanoscope Clinical Site
Phoenix, Arizona, 85020
Nanoscope Clincal Site
San Antonio, Texas, 78240
About this study
Official title: A Prospective Multi-Center Observational Study to Assess the Reliability and Validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Test (MLSDT)
This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Study (MLSDT) Main Outcome Measures: (i) Performance scores in normal and severely visually impaired subjects with a clinical diagnosis of retinitis pigmentosa (RP) on MLYMT and MLSDT at multiple luminance levels and (ii) reliability and content validity of MLYMT and MLSDT.
Read the detailed description
Two assessment visits will be conducted in order to evaluate functional visual performance in severely vision impaired subjects with RP and normally sighted subjects. Two visits will occur at week 0 and week 4 with functional vision assessments occurring at both visits in order to assess visit-to-visit variability. For the MLYMT, navigational vision will be assessed using each eye and binocularly at up to 6 different light levels (range 0.3 to 100 lux). Subjects will also perform the Multi-Luminance Shape Discrimination Test (MLSDT) which assesses near object recognition under different lighting levels. MLYMT and MLSDT performance will be evaluated together with Best Corrected Visual Acuity (BCVA), Visual Field (VF) and responses to visual function questionnaires. Subjects will be assigned to one of two cohorts based on presence or absence of RP in addition to BCVA performance.
- Conditions
- Retinitis Pigmentosa, Retinal Dystrophy
- Being tested
- Observational
- Keywords
- Retinitis Pigmentosa, Inherited Retinal Diseases, Eye Diseases, Retinal Degeneration, Mobility Test, Multi-luminance Y- Mobility Test
- Medical subject headings
- Retinitis Pigmentosa, Retinal Dystrophies, Eye Diseases, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
The goal of this observational study is to assess the reliability and validity of the multi-luminance Y-Mobility Test (MLYMT) and multi-luminance shape description test (MLSDT) for evaluation of subjects with severe vision impairment due to RP.
Normally sighted subjects will provide a control group. The MLYMT consists of two LED panels, one of which is illuminated at multiple luminance levels, positioned at the end of Y-configuration. Seven obstacles are placed ahead of the panels, which the test subject should detect and avoid before reaching and touching the lit panel.
| Study group | Role | What they receive |
|---|---|---|
| Normally Sighted | Participants with clinically normal ocular findings and BCVA better than logMAR 0.3 in each eye. Receives: Other: Observational | |
| Severely Sight Impaired | Participants with BCVA no better than logMAR 1.6 in better seeing eye, and worse than logMAR 1.9 in the worse seeing eye, and a clinical diagnosis of advanced RP Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
MLYMT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLYMT
A higher MLYMT score (range -1 to 5) indicates better navigational vision.
Measured: 4 Weeks
MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLSDT
A higher MLSDT score (range 0 to 5) indicates greater shape discrimination ability at lower luminance level
Measured: 4 Weeks
Reliability and construct validity of MLYMT
Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity
Measured: 4 Weeks
Reliability and construct validity of MLSDT
Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start25 Apr 2023
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanoscope Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Samarendra Mohanty, Study chair, Nanoscope Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820100
- Sponsor's protocol ID
- NTXOBS-001
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of the clinical trial will be made available when the study is completed. The results will be published on this site and be available to conference presentations and publications.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Observational Study to Assess the Reliability and Validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Test (MLSDT)
- ClinicalTrials.gov ID
- NCT05820100
- Acronym / sponsor ID
- NTXOBS-001
- Conditions
- Retinitis Pigmentosa, Retinal Dystrophy
- Keywords
- Retinitis Pigmentosa, Inherited Retinal Diseases, Eye Diseases, Retinal Degeneration, Mobility Test, Multi-luminance Y- Mobility Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nanoscope Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Study (MLSDT) Main Outcome Measures: (i) Performance scores in normal and severely visually impaired subjects with a clinical diagnosis of retinitis pigmentosa (RP) on MLYMT and MLSDT at multiple luminance levels and (ii) reliability and content validity of MLYMT and MLSDT.
Detailed description
Two assessment visits will be conducted in order to evaluate functional visual performance in severely vision impaired subjects with RP and normally sighted subjects. Two visits will occur at week 0 and week 4 with functional vision assessments occurring at both visits in order to assess visit-to-visit variability. For the MLYMT, navigational vision will be assessed using each eye and binocularly at up to 6 different light levels (range 0.3 to 100 lux). Subjects will also perform the Multi-Luminance Shape Discrimination Test (MLSDT) which assesses near object recognition under different lighting levels. MLYMT and MLSDT performance will be evaluated together with Best Corrected Visual Acuity (BCVA), Visual Field (VF) and responses to visual function questionnaires. Subjects will be assigned to one of two cohorts based on presence or absence of RP in addition to BCVA performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normally Sighted | – | Other: ObservationalParticipants with clinically normal ocular findings and BCVA better than logMAR 0.3 in each eye. |
| Severely Sight Impaired | – | Other: ObservationalParticipants with BCVA no better than logMAR 1.6 in better seeing eye, and worse than logMAR 1.9 in the worse seeing eye, and a clinical diagnosis of advanced RP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll approximately 35 adult subjects, to one of 2 cohorts. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Able to comprehend and give informed consent.
- Able to comply with testing and all protocol tests.
- Eligible for 1 of 2 cohorts listed below:
- Cohort 1: Normally Sighted Participants with clinically normal ocular findings and BCVA better than logMAR 0.3 (as confirmed by ETDRS letter score > 73) in each eye Cohort 2: Severely Sight Impaired Participants with BCVA no better than logMAR 1.6 in better seeing eye, and worse than LogMAR 1.9 in the worse seeing eye, and a clinical diagnosis of advanced RP
Key exclusion criteria (6 listed)
- Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months
- Presence of any condition other than RP Disease that impairs visual acuity or visual fields e.g., visually significant cataract or visual field loss in glaucoma
- Presence of neurological condition that impairs visual acuity or visual field, e.g., hemianopia secondary to stroke
- Individuals who refuse or are incapable of performing mobility testing
- Individuals with retinal prosthesis (such as ARGUS-II)
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 |
|---|---|---|
| ObservationalThe goal of this observational study is to assess the reliability and validity of the multi-luminance Y-Mobility Test (MLYMT) and multi-luminance shape description test (MLSDT) for evaluation of subjects with severe vision impairment due to RP. Normally sighted subjects will provide a control group. The MLYMT consists of two LED panels, one of which is illuminated at multiple luminance levels, positioned at the end of Y-configuration. Seven obstacles are placed ahead of the panels, which the test subject should detect and avoid before reaching and touching the lit panel. | Other | Normally Sighted, Severely Sight Impaired |
Primary outcome
MLYMT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLYMT
Time frame: 4 Weeks
A higher MLYMT score (range -1 to 5) indicates better navigational vision.
MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLSDT
Time frame: 4 Weeks
A higher MLSDT score (range 0 to 5) indicates greater shape discrimination ability at lower luminance level
Reliability and construct validity of MLYMT
Time frame: 4 Weeks
Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity
Reliability and construct validity of MLSDT
Time frame: 4 Weeks
Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Yes. The results of the clinical trial will be made available when the study is completed. The results will be published on this site and be available to conference presentations and publications.
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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.
Dr Samarendra Mohanty study chair
Nanoscope Therapeutics Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa and Retinal Dystrophy, run by Nanoscope Therapeutics Inc. at 8 sites in 2 countries.
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 5 inclusion and 6 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MLYMT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLYMT (time frame: 4 Weeks). The study lists 4 primary outcomes in all. 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 5 Jan 2024.