Natural history 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
This project will test whether color vision problems relate to retinal structure and visual function in people with inherited retinal dystrophies and in people without retinal disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Zhongmou Therapeutics Industry-sponsored |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT07085533 on ClinicalTrials.gov |
What this trial studies
This prospective observational study will enroll about 200 participants, including a heterogeneous group of patients with inherited retinal dystrophies (across genotypes and severities) and control participants without retinal disease. All participants will complete a standardized battery including quantitative color vision testing, best-corrected visual acuity (BCVA), and advanced multimodal retinal imaging such as spectral-domain OCT to measure ellipsoid zone (EZ) integrity and retinal thickness. The study will integrate imaging metrics with clinical and genotypic data to characterize relationships between color discrimination deficits and outer retinal microstructure. The principal focus is on linking impairments in color vision to morphological disruptions of the EZ and other retinal biomarkers.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of an inherited retinal dystrophy who can identify and describe colors and communicate during testing, along with control participants who have no retinal disease and normal color vision.
Not a fit: Patients whose color vision loss is due to non‑retinal causes (for example optic neuropathy) or who cannot reliably perform color testing because of cognitive or communication limitations are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could help clinicians use color vision tests and retinal imaging to better predict visual function and to inform patient selection and outcome measures for future therapies.
How similar studies have performed: Previous work, particularly in retinitis pigmentosa cohorts, has shown correlations between ellipsoid zone integrity and chromatic discrimination, so this protocol builds on existing evidence rather than being wholly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. 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 3. 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 Exclusion Criteria: 1. 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 2. 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 3. 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
Where this trial is running
Wuhan
- Renmin Hospital of Wuhan University — Wuhan, China (Recruiting)
Study contacts
- Principal investigator: Yin Shen — Renmin Hospital of Wuhan University
- Study coordinator: Wenhui Zhou
- Email: mojtaba98shirinzadeh@gmail.com
- Phone: +86 15527905531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.