NCT07088796

Toric Intraocular Lens Implantation for Pediatric Aphakia

Toric Intraocular Lens Implantation in Pediatric Aphakia (Ages 3-8 Years): A Prospective Nonrandomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2017-10-07
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2025-07-28
• Last updated: 2025-09-08

Locations

1 site across 1 country: China