Toric Intraocular Lens Implantation for Pediatric Aphakia

Not Applicable

Completed

• Conditions: Pediatric Cataract; Congenital Cataract

• Registration Number: NCT07088796
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

Here, we conducted a nonrandomized clinical trial aims to evaluate and compare the prognosis of visual function in children of these two types of IOL implantation over a three-year postoperative period.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-07
• Primary Completion: 2024-10-18
• Study Completion: 2024-10-18
• Status Verified: 2025-07
• Study First Submitted: 2025-07-19
• Study First Submitted QC: 2025-07-19
• Last Update Submitted: 2025-07-19
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

1. aged 3 to 8 years and diagnosed as pediatric cataract; 2) at least 2.0 D of regular corneal astigmatism.

Exclusion Criteria

1)history of ocular comorbidities such as such as glaucoma, retinal detachment, persistent fetal vasculature, and any retina-related pathologies; 2)history of ocular trauma or surgery; 3) concurrent severe systemic diseases; 4) lack of cooperation with slit-lamp examination, pentcam, IOL master700, subjective manifest refraction and other eye examinations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BCVA at 3 years after surgery	3 years after surgery

Secondary Outcome Measures

Name	Time	Method
IOP	Postoperative day 1, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
Axial length	Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
stereopsis	Postoperative 6 months, 1 year, 2 years, and 3 years
residual astigmatism	Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
UDVA	Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years.
CDVA	Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
Corneal astigmatism	Postoperative 1month, 3 months, 6 months, 1 year, 2 years, and 3 years.
spherical equivalent	Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years.
IOL rotation	Postoperative 1 week, 2 weeks, and 1 month.

Trial Locations

Locations (1)

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