Clinical trial NCT05820100: Observational Study to Assess the Reliability and Validity of the MLYMT and MLSDT
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinitis Pigmentosa
Retinal Dystrophy
Keywords: Retinitis Pigmentosa
Inherited Retinal Diseases
Eye Diseases
Retinal Degeneration
Mobility Test
Multi-luminance Y- Mobility Test
Lead sponsor: Nanoscope Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Able to comprehend and give informed consent.
3. Able to comply with testing and all protocol tests.
4. 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

Exclusion Criteria:

1. Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months
2. 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
3. Presence of neurological condition that impairs visual acuity or visual field, e.g., hemianopia secondary to stroke
4. Individuals who refuse or are incapable of performing mobility testing
5. Individuals with retinal prosthesis (such as ARGUS-II)
6. Participation in Nanoscope studies NTXMCO-002 (RESTORE) or NTXMCO-004 (STARLIGHT)

Primary outcomes:
measure: MLYMT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLYMT
timeFrame: 4 Weeks
measure: MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLSDT
timeFrame: 4 Weeks
measure: Reliability and construct validity of MLYMT
timeFrame: 4 Weeks
measure: Reliability and construct validity of MLSDT
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Nanoscope Clinical Site
state: Arizona
city: Beverly Hills
country: United States
facility: Nanoscope Clinical Site
state: California
city: Miami
country: United States
facility: Nanoscope Clinical Site
state: Florida
city: Fargo
country: United States
facility: Nanoscope Clinical Site
state: North Dakota
city: Bellaire
country: United States
facility: Nanoscope Clinical Site
state: Texas
city: McAllen
country: United States
facility: Nanoscope Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Nanoscope Clincal Site
state: Texas
city: Arecibo
country: Puerto Rico
facility: Nanoscope Clinical Site
Study officials:
affiliation: Nanoscope Therapeutics Inc.
name: Dr Samarendra Mohanty
role: STUDY_CHAIR
References: