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Completed

NCT Number: NCT05820100

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

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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinal Dystrophy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanoscope Clinical Site, Arecibo, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. MLYMT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLYMT

    Time frame: 4 Weeks

    A higher MLYMT score (range -1 to 5) indicates better navigational vision.

  2. MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of RP on MLSDT

    Time frame: 4 Weeks

    A higher MLSDT score (range 0 to 5) indicates greater shape discrimination ability at lower luminance level

  3. Reliability and construct validity of MLYMT

    Time frame: 4 Weeks

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

  4. Reliability and construct validity of MLSDT

    Time frame: 4 Weeks

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

Sponsors and collaborators

Lead sponsor

Nanoscope Therapeutics Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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