Toric Intraocular Lens Implantation for Pediatric Aphakia

NCT07088796 | Completed DMC

• 2 other identifiers: EENT No. 2013021No. 2013021
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cataract; Congenital Cataract

Keywords

astigmatism; amblyopia; toric IOL

Outcome Measures

Primary Outcomes (1)

• BCVA at 3 years after surgery

  3 years after surgery

Secondary Outcomes (9)

• 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

• 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

Study Arms (2)

toric group

EXPERIMENTAL

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.

Device: Toric IOL implantation

non-toric group

ACTIVE COMPARATOR

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.

Device: Non-toric IOL implantation

Interventions

Toric IOL implantation 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.

toric group

Non-toric IOL implantation 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.

non-toric group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye and ENT hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Astigmatism; Amblyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Yang, Ph.D

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analysts and investigators who observed patient outcomes during follow-up were blinded to minimize bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: October 7, 2017
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CN (1)