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

NCT05820100 | Completed

• 1 other identifier: NTXOBS-001
• Study Type: observational
• Target: 35
• Locations: 2 countries
• Sites: 8

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.

Conditions

Retinitis Pigmentosa; Retinal Dystrophy

Keywords

Retinitis Pigmentosa; Inherited Retinal Diseases; Eye Diseases; Retinal Degeneration; Mobility Test; Multi-luminance Y- Mobility Test

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Reliability and construct validity of MLYMT

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

  4 Weeks

• Reliability and construct validity of MLSDT

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

  4 Weeks

Study Arms (2)

Normally Sighted

Participants with clinically normal ocular findings and BCVA better than logMAR 0.3 in each eye.

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

Other: Observational

Interventions

Observational OTHER

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.

Normally Sighted; Severely Sight Impaired

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanoscope Therapeutics Inc.: lead

Study Sites (8)

Nanoscope Clinical Site

Phoenix, Arizona, 85020, United States

Location

Nanoscope Clinical Site

Beverly Hills, California, 90211, United States

Location

Nanoscope Clinical Site

Miami, Florida, 33136, United States

Location

Nanoscope Clinical Site

Fargo, North Dakota, 58103, United States

Location

Nanoscope Clinical Site

Bellaire, Texas, 77401, United States

Location

Nanoscope Clinical Site

McAllen, Texas, 78503, United States

Location

Nanoscope Clincal Site

San Antonio, Texas, 78240, United States

Location

Nanoscope Clinical Site

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Retinitis Pigmentosa; Retinal Dystrophies; Eye Diseases; Retinal Degeneration

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Dr Samarendra Mohanty

  Nanoscope Therapeutics Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 25, 2023
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: 12 months after the study is completed
• Access Criteria: Reliability and Validity of MLYMT and MLSDT

Locations

US (7); PR (1)