Toric Intraocular Lens Implantation for Pediatric Aphakia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-07

Study Completion Date

2024-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Cataract Congenital Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The data analysts and investigators who observed patient outcomes during follow-up were blinded to minimize bias

Study Groups

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toric group

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.

Group Type EXPERIMENTAL

Toric IOL implantation

Intervention Type DEVICE

All surgeries were performed by the same surgeon (J.Y.) using a standardized surgical technique (phacoemulsification for cataract extraction+ IOL implantation + anterior vitrectomy) under general anesthesia. Scleral tunnel incision was created firstly. Thereafter, 5.0-5.2mm anterior capsule capsulorrhexis, and cataract aspiration were performed. A single-piece hydrophobic acrylic IOL (SN6AT3-T9) was implanted into the capsular bag. After the corneal incision was closed with 10-0 sutures, a posterior capsulectomy of 3-4 mm and anterior vitrectomy were performed through the pars plana using 25-gauge instrumentation with high cutting frequency (3,000 to 4,000 cuts per minute) and low aspiration pressure (300 to 350 mm Hg) in all eyes. A 3.5-4.0 mm posterior capsule capsulorrhexis and anterior vitrectomy were performed in patients.

non-toric group

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.

Group Type ACTIVE_COMPARATOR

Non-toric IOL implantation

Intervention Type DEVICE

All surgeries were performed by the same surgeon (J.Y.) using a standardized surgical technique (phacoemulsification for cataract extraction+ IOL implantation + anterior vitrectomy) under general anesthesia. Scleral tunnel incision was created firstly. Thereafter, 5.0-5.2mm anterior capsule capsulorrhexis, and cataract aspiration were performed. A single-piece hydrophobic acrylic IOL (SN60WF) was implanted into the capsular bag. After the corneal incision was closed with 10-0 sutures, a posterior capsulectomy of 3-4 mm and anterior vitrectomy were performed through the pars plana using 25-gauge instrumentation with high cutting frequency (3,000 to 4,000 cuts per minute) and low aspiration pressure (300 to 350 mm Hg) in all eyes. A 3.5-4.0 mm posterior capsule capsulorrhexis and anterior vitrectomy were performed in patients.

Interventions

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Toric IOL implantation

All surgeries were performed by the same surgeon (J.Y.) using a standardized surgical technique (phacoemulsification for cataract extraction+ IOL implantation + anterior vitrectomy) under general anesthesia. Scleral tunnel incision was created firstly. Thereafter, 5.0-5.2mm anterior capsule capsulorrhexis, and cataract aspiration were performed. A single-piece hydrophobic acrylic IOL (SN6AT3-T9) was implanted into the capsular bag. After the corneal incision was closed with 10-0 sutures, a posterior capsulectomy of 3-4 mm and anterior vitrectomy were performed through the pars plana using 25-gauge instrumentation with high cutting frequency (3,000 to 4,000 cuts per minute) and low aspiration pressure (300 to 350 mm Hg) in all eyes. A 3.5-4.0 mm posterior capsule capsulorrhexis and anterior vitrectomy were performed in patients.

Intervention Type DEVICE

Non-toric IOL implantation

All surgeries were performed by the same surgeon (J.Y.) using a standardized surgical technique (phacoemulsification for cataract extraction+ IOL implantation + anterior vitrectomy) under general anesthesia. Scleral tunnel incision was created firstly. Thereafter, 5.0-5.2mm anterior capsule capsulorrhexis, and cataract aspiration were performed. A single-piece hydrophobic acrylic IOL (SN60WF) was implanted into the capsular bag. After the corneal incision was closed with 10-0 sutures, a posterior capsulectomy of 3-4 mm and anterior vitrectomy were performed through the pars plana using 25-gauge instrumentation with high cutting frequency (3,000 to 4,000 cuts per minute) and low aspiration pressure (300 to 350 mm Hg) in all eyes. A 3.5-4.0 mm posterior capsule capsulorrhexis and anterior vitrectomy were performed in patients.

Intervention Type DEVICE