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

N/ACompletedNCT05820100

Nanoscope Therapeutics Inc.35 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Retinitis Pigmentosa Retinal Dystrophy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (8)

Nanoscope Clinical Site

Phoenix, Arizona, United States

Nanoscope Clinical Site

Beverly Hills, California, United States

Nanoscope Clinical Site

Miami, Florida, United States

Nanoscope Clinical Site

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 4 Weeks

Reliability and construct validity of MLYMT

Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity

Time frame: 4 Weeks

Reliability and construct validity of MLSDT

Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity

Time frame: 4 Weeks

Data from ClinicalTrials.gov

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