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

Sun Yat-sen University

Status: Enrolling

Conditions: Ectopia Lentis; Dislocation, Lens

Study type: Observational

Funder types: Other

Identifiers

NCT05654025

2022KYPJ207

Details and patient eligibility

About

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.

Full description

Congenital ectopia lens is a rare ophthalmic disease that seriously harms the physical and mental health of patients. Surgery is the only definite treatment at present. However, the changes in vision-related quality of life, mental health status, ocular biological parameters postoperative congenital dislocation of lens have not been systematically studied in the Chinese population.

In this trial, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients, investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis, explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis, and explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.

Enrollment: 604 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

604 participants in 2 patient groups

Non-surgical group: Refractive change, ocular parameter changes, and prognosis without surgery

Description:

To evaluate the long-term changes in refractive state, ocular parameter, ocular development and visual prognosis in patients without congenital ectopia lentis surgery.

Surgical group: Safety and efficacy of different congenital ectopia lentis surgeries

Description:

To compare the safety and efficacy of different congenital ectopia lentis surgeries, including phacoemulsification， phacoemulsification + Intraocular lens (IOL) implantation， phacoemulsification + IOL implantation + Capsular Tension Ring implantation or phacoemulsification + IOL implantation + transscleral fixation.