Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery

Recruiting

• Conditions: Congenital Cataract; Pediatric Cataract

• Registration Number: NCT07070037
• Lead Sponsor: Jin Yang

Brief Summary

This prospective multicenter observational study aims to evaluate the 5-year visual function and refractive outcomes in children undergoing surgery for congenital cataract. Key outcomes include best-corrected visual acuity, stereopsis, refractive error, and axial length growth. The study will help identify long-term trends and prognostic indicators after early cataract intervention in pediatric patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-07-15
• Study First Posted: 2025-07-17
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-08-20
• Primary Completion: 2030-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Diagnosis of congenital cataract
• Underwent cataract extraction before 1 year of age
• Available for regular follow-up for at least 5 years postoperatively
• Written informed consent from legal guardian

Exclusion Criteria

• Acquired cataract or traumatic origin
• Associated ocular malformations (e.g., microphthalmia, coloboma)
• Systemic syndromes affecting vision (e.g., Down syndrome)
• History of secondary surgery affecting visual outcome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Acuity	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	UDVA and BCVA will be assessed using age-appropriate optotypes (e.g., Snellen chart, ETDRS chart, or Lea symbols) and recorded in logMAR units at the last available follow-up, with a minimum duration of 5 years postoperatively.
axial length	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	AL
Refractive Error	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	Refractive Error

Secondary Outcome Measures

Name	Time	Method
IOP	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	intraocular pressure
Corneal Curvature (K1 and K2) by Pentacam	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	Flat (K1) and steep (K2) corneal curvature values will be measured using Pentacam and recorded in diopters (D).
Stereopsis	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	Stereopsis will be assessed using age-appropriate tools (e.g., Randot Preschool or Titmus Fly Test) and reported in seconds of arc. Loss of stereopsis is defined as \>3000 arcsec.
white to white	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	WTW (mm)
anterior chamber depth	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	ACD(mm)
Complications	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	Any postoperative complications following congenital cataract surgery, including glaucoma, anterior capsular opacification (ACO), etc.
Central Corneal Thickness (CCT)	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	Corneal pachymetry will be measured with Pentacam at the central point and reported in microns (µm).
Corneal Astigmatism Magnitude	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	Corneal astigmatism will be calculated from the difference between steep and flat meridians (K2-K1) using Pentacam data, and reported in diopters.
Binocular Fusion Assessment	Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.	Binocular fusion will be evaluated using the Worth 4-Dot test under near and distance conditions. Results will be categorized as "fusion", "suppression", or "alternation".

Trial Locations

Locations (1)

Eye and ENT hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China