Toric Intraocular Lens Implantation in Pediatric Cataract (TILIPC)

Kazakh Eye Research Institute

Status: Active, not recruiting

Conditions: Cataract Congenital; Astigmatism; IOL

Treatments: Procedure: congenital/pediatric cataract surgery; Device: Toric IOLs; Device: Non-Toric IOLs

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06294795

02-2024

Details and patient eligibility

About

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

Full 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 intraocular lens (IOL) 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Visually significant cataract;
2. Corneal astigmatism more than 1.25 diopters;
3. Children aged ≥ 6 years and < 18 years.

Exclusion criteria

1. Patients with a corneal diameter less than 9 mm;
2. Presence of corneal scarring;
3. Irregular astigmatism;
4. Intraocular pressure more than 25 mm Hg;
5. Active inflammatory process of the eyeball or signs of a previous episode of inflammation;
6. Traumatic, subluxated, or complicated cataract;
7. Persistent Fetal Vasculature;
8. Diseases of the optic nerve or macula that may limit visual potential;
9. History of previous intraocular surgeries;
10. Performing posterior capsulorhexis intraoperatively.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Toric

Experimental group

Description:

A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx

Treatment:

Device: Toric IOLs

Procedure: congenital/pediatric cataract surgery

Non-toric

Active Comparator group

Description:

A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF

Treatment:

Device: Non-Toric IOLs

Procedure: congenital/pediatric cataract surgery