Observational Study to Assess the Reliability and Validity of the MLYMT and MLSDT

Completed

• Conditions: Retinitis Pigmentosa; Retinal Dystrophy
• Interventions: Other: Observational

• Registration Number: NCT05820100
• Lead Sponsor: Nanoscope Therapeutics Inc.

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.

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-19
• Study Start: 2023-04-25
• Primary Completion: 2023-10-17
• Study Completion: 2023-10-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normally Sighted	Observational	Participants with clinically normal ocular findings and BCVA better than logMAR 0.3 in each eye.
Severely Sight Impaired	Observational	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

Primary Outcome Measures

Name	Time	Method
Reliability and construct validity of MLYMT	4 Weeks	Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity
Reliability and construct validity of MLSDT	4 Weeks	Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity
MLYMT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLYMT	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	4 Weeks	A higher MLSDT score (range 0 to 5) indicates greater shape discrimination ability at lower luminance level

Trial Locations

Locations (2)

Nanoscope Clinical Site; 🇵🇷 Arecibo, Puerto Rico

Nanoscope Clincal Site; 🇺🇸 San Antonio, Texas, United States