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

Retinitis Pigmentosa Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05820100
• Other study ID #: NTXOBS-001
• Status: Completed
• Start date: April 25, 2023
• Est. completion date: October 17, 2023

Study information

• Verified date: January 2024
• Source: Nanoscope Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 of retinitis pigmentosa (RP) on MLYMT and MLSDT at multiple luminance levels and (ii) reliability and content validity of MLYMT and MLSDT.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Retinal Dystrophies
• Retinal Dystrophy
• Retinitis
• Retinitis Pigmentosa

Intervention

Other:
• Observational
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.

Locations

Country	Name	City	State
Puerto Rico	Nanoscope Clinical Site	Arecibo
United States	Nanoscope Clinical Site	Bellaire	Texas
United States	Nanoscope Clinical Site	Beverly Hills	California
United States	Nanoscope Clinical Site	Fargo	North Dakota
United States	Nanoscope Clinical Site	McAllen	Texas
United States	Nanoscope Clinical Site	Miami	Florida
United States	Nanoscope Clinical Site	Phoenix	Arizona
United States	Nanoscope Clincal Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nanoscope Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 Weeks
Primary	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	4 Weeks
Primary	Reliability and construct validity of MLYMT	Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity	4 Weeks
Primary	Reliability and construct validity of MLSDT	Evaluation of the performance (test-retest reliability) of the test(s) based on the visual acuity	4 Weeks