Toric Intraocular Lens Implantation for Pediatric Aphakia

NACompletedINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

October 7, 2017

Primary Completion Date

October 18, 2024

Study Completion Date

October 18, 2024

Conditions
Pediatric CataractCongenital Cataract
Interventions
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.

Trial Locations (1)

200032

Eye and ENT hospital Fudan University, Shanghai

All Listed Sponsors
lead

Eye & ENT Hospital of Fudan University

OTHER

NCT07088796 - Toric Intraocular Lens Implantation for Pediatric Aphakia | Biotech Hunter | Biotech Hunter