Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens

NCT05654025 · tracked via the Priya Life Science China tracker

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Phase

Observational

Started

2022-12-05

Last updated

2024-08-07

Condition(s) studied

Ectopia LentisDislocation, Lens

Study summary

This is a single-centre, observational cohort study with the following objectives: Firstly, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients. Secondly, the investigators target to investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis. Thirdly, to explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis. Lastly, this study aims to explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.

Eligibility

Sex

ALL

Min age

3 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Diagnosed with congenital lens dislocation and age ≥ 3 years old. * Agree to participate in this study with written informed consent from patients or legal guardians. Exclusion Criteria: * History of ophthalmic trauma or other ophthalmic surgeries. * Combined with other ophthalmic diseases such as primary glaucoma, uveitis and corneal disease. * Patients who could not cooperate in the examinations.

Primary outcome measure(s)

Change of best corrected visual acuity — Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation
Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each visit.
Incidence of complications — Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation.
Estimate the incidence of complications for both non-surgical group and surgical group.

Trial sites (1)

Facility	City	Region	Status
Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science	Guangzhou	Guangdong	Recruiting

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Other trials for the same condition

Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children Recruiting

Effect of Mobile Communication on Congenital Ectopia Lentis Follow-up Adherence Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05654025 on ClinicalTrials.gov ↗ ← All trials in China