Toric Intraocular Lens Implantation for Pediatric Aphakia

Eye & ENT Hospital of Fudan University

Status: Completed

Conditions: Pediatric Cataract; Congenital Cataract

Treatments: Device: Non-toric IOL implantation; Device: Toric IOL implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07088796

No. 2013021 (Other Identifier)

EENT No. 2013021

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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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.

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Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

toric group

Experimental group

Description:

Name of Intervention: Implantation of AcrySof IQ Toric Intraocular Lens (IOL) SN6AT3-T9 Manufacturer: Alcon Laboratories, Inc. Details of Intervention: The intervention involves the surgical implantation of a toric intraocular lens (IOL) in pediatric cataract patients. This specific IOL model (SN6AT3-T9) is designed to correct astigmatism.

Treatment:

Device: Toric IOL implantation

non-toric group

Active Comparator group

Description:

Name of Intervention: Implantation of AcrySof IQ Hydrophobic Acrylic Intraocular Lens (IOL) SN60WF Manufacturer: Alcon Laboratories, Inc. Details of Intervention: The control intervention involves the surgical implantation of a non-toric, hydrophobic acrylic intraocular lens (IOL) in pediatric cataract patients. This IOL model (SN60WF) provides clear vision but does not correct pre-existing corneal astigmatism.

Treatment:

Device: Non-toric IOL implantation