NCT07085533Recruiting
Natural History Study of Inherited Retinal Diseases
Color Vision Loss Progression in IRD Patients: Retinal Structural Changes Correlations, and a Novel Color Discrimination Test for Extreme Low Vision Patients
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
This prospective, observational investigation seeks to delineate the interplay between chromatic vision deficits and both functional visual outcomes and anatomical retinal biomarkers in individuals affected by Inherited Retinal Dystrophies (IRDs). The study will recruit approximately 200 subjects, encompassing a heterogeneous population of IRD patients-spanning a range of genotypes and clinical severities-as well as control participants devoid of retinal pathology. All enrolled individuals will undergo a standardized battery of evaluations, including quantitative color vision assessment, best-corrected visual acuity (BCVA) determination, and advanced multimodal retinal imaging. The principal aim is to characterize the relationship between impairments in color discrimination and morphologic disruptions within the outer retinal layers, with particular emphasis on the continuity and reflectivity of the ellipsoid zone (EZ)-historically referred to as the inner segment/outer segment (IS/OS) junction-assessed through spectral-domain optical coherence tomography (SD-OCT). Further, the study will explore associations between chromatic perceptual deficits and underlying genetic mutations, mutation patterns specific to IRD subtypes, and the influence of patient age on the severity and progression of color vision loss. A key secondary objective is the clinical appraisal and validation of a novel diagnostic modality, the Moji Low-Vision Color Discrimination Test (Moji Test), which is specifically engineered to quantify residual color perception in individuals with advanced central visual impairment. The test's discriminatory capacity will be benchmarked against established color vision testing paradigms to assess its reliability, clinical sensitivity, and suitability for implementation in populations with severe visual acuity reduction. By incorporating a genetically and phenotypically diverse IRD cohort, the study is designed to enable granular, stratified analyses that will refine the understanding of structural-functional correlations in hereditary retinal disease. The inclusion of a control group with preserved retinal architecture and normal color vision function will provide essential normative baselines for comparative evaluation and statistical inference.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 20 Jul 2025
- Primary completion date
- 4 Jun 2027
- Lead sponsor
- Augelux Therapeutics
- Diseases
- Macular degeneration
- NCT number
- NCT07085533
What you commit to
- Study type: Observational
- Planned participants: 200
- From 20 Jul 2025 to the primary completion date, 4 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with potential transient effects on the retina
- Recent retinal surgery
- Recent drug therapy affecting retinal structure or function
- Any acute intervention that might confound the correlation analyses due to lack of a stable baseline
Other illness
- Psychological or cognitive conditions affecting color perception or communication
- Severe developmental delays
- Cognitive impairments interfering with ability to comprehend or reliably perform color vision tests
- Psychiatric conditions that impair visual interpretation or reliable testing
Other
- Non retinal causes of color vision loss
- Optic neuropathies (e.g., optic neuritis, glaucoma related optic nerve damage)
- Cortical vision impairments affecting color perception
- Any other neurological or optic nerve pathology causing color vision deficiency
Who the study is looking for
- Color Perception and Communication Ability Participants must have the ability to verbally identify or describe colors and test stimuli. This requires adequate cognitive and communicative capacity to understand instructions and respond appropriately during color vision testing.
- Diagnosis of Inherited Retinal Dystrophy (IRD Group Only) Participants assigned to the IRD group must have a confirmed clinical diagnosis of an inherited retinal dystrophy
- No Evidence of Inherited Retinal Disease (Control Group Only)
- Participants in the control group must have:
- No known history or clinical evidence of inherited retinal degeneration
- Normal retinal health or only non-retinal ocular conditions not affecting retinal function (e.g., mild cataract, corrected refractive error)
- Normal or expected-normal color vision
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.