Visual Function in Pediatric Patients With Posterior Lens Opacities

NCT ID: NCT05207007

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-04
• Study Completion Date: 2021-08-29

Brief Summary

Prognostic factors determining visual outcomes in patients with posterior polar cataracts and posterior lenticonus are largely unknown. In this trial, the investigators aimed to evaluate the visual outcomes in patients with posterior polar cataracts and posterior lenticonus and try to find out the factors associated with the visual acuity after surgery. Patients enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

Detailed Description

Congenital cataract patients have a wide range of presentations of lens opacities with different impact on visual function. Polar cataracts are opacities of the subcapsular cortex in the polar regions of the lens. To our knowledge, anterior polar cataracts are usually visually insignificant, however, even a small posterior lens opacity can impair vision because of their close proximity to the macula. Visual impairment could be caused by an opacity that blocks the visual axis, refractive error, posterior lesion-induced optical distortion, or amblyopia. Therefore, surgery is often recommended when visual function is significantly affected. The primary indication for surgical intervention in cataract is poor visual acuity. However, the previous studies have shown that preoperative visual acuity is a poor predictor of improvement in the subjectively experienced quality of vision after cataract surgery. Considering the increased risk for capsule rupture during surgery and the sacrifice of accommodation after cataract surgery in eyes with posterior lens opacities, the decision of surgical intervention must be carefully weighed.

In this trial, the investigators aimed to evaluate the changes of visual function, including visual acuity, modulation transfer function, ocular aberrations in the participants with posterior lens opacities. Moreover, various factors which might be associated with postoperative visual acuity were explored. The participants enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

Conditions

Congenital Cataract Polar Posterior

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

posterior polar cataracts

Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients.

Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation

Intervention Type: PROCEDURE

Phacomulsification lens removal cataract surgery with IOL implantation in both two groups

posterior lenticonus

Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients.

Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation

Intervention Type: PROCEDURE

Phacomulsification lens removal cataract surgery with IOL implantation in both two groups

Interventions

Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation

Phacomulsification lens removal cataract surgery with IOL implantation in both two groups

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children with posterior polar cataracts or posterior lenticonus who need cataract surgery
• Aged 3-14 years
• Have signed a consent form
• Can be followed

Exclusion Criteria

• Have relevant ocular disease other than congenital cataract
• Could not cooperate to the examinations

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Haotian Lin

Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weirong Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, , China

Countries

China

Other Identifiers

CCPMOH2020-China20

Identifier Type: -

Identifier Source: org_study_id