Toric Intraocular Lens Implantation in Pediatric Cataract

Not Applicable

Active, not recruiting

• Conditions: Cataract Congenital; Astigmatism; IOL
• Interventions: Procedure: congenital/pediatric cataract surgery; Device: Toric IOLs; Device: Non-Toric IOLs

• Registration Number: NCT06294795
• Lead Sponsor: Kazakh Eye Research Institute

Brief Summary

To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism

Detailed Description

This single-center, single-blinded, prospective, randomized controlled trial was performed at two sites of Kazakh Eye Research Institute.

Children with pediatric cataract and corneal astigmatism were included and randomized to two groups for pediatric cataract surgery with toric and non-toric IOLs implantation. The uncorrected and corrected distance visual acuity, near visual acuity, keratometry data, and residual astigmatism were evaluated.

The purpose of this study is to evaluate the visual and refractive outcomes after a toric IOL implantation in pediatric eyes with cataract and preexisting corneal astigmatism.

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study Start: 2024-03-01
• Study First Posted: 2024-03-06
• Primary Completion: 2025-02-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toric	congenital/pediatric cataract surgery	A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF
Toric	Toric IOLs	A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF
Non-toric	congenital/pediatric cataract surgery	A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx
Non-toric	Non-Toric IOLs	A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx

Primary Outcome Measures

Name	Time	Method
Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity	recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)	measured using the Lea symbol visual acuity chart or the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart according to the patient\'s age
Uncorrected (UCNVA) and corrected (CNVA) near visual acuity	recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)	measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient\'s age
Refraction measurements	recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)	obtained with KR-1W Wavefront Analyzer

Secondary Outcome Measures

Name	Time	Method
Keratometry measurements	recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)	obtained with KR-1W Wavefront Analyzer

Trial Locations

Locations (1)

Kazakh Eye Research Institute; 🇰🇿 Astana, Kazakhstan