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

Completed

Conditions studied: Retinitis Pigmentosa, Retinal Dystrophy

In brief

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.

Key facts

Study ID

NCT05820100

Run by

Nanoscope Therapeutics Inc.

People needed

35

Starts

2023-04-25

Expected to finish

2023-10-17

Last updated by the study team

2024-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• 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
• Nanoscope Clinical Site — Bellaire, Texas, United States
• Nanoscope Clinical Site — McAllen, Texas, United States
• Nanoscope Clincal Site — San Antonio, Texas, United States
• Nanoscope Clinical Site — Arecibo, Puerto Rico

Full record on ClinicalTrials.gov

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