An interventional study of Toric IOL implantation and Non-toric IOL implantation in Pediatric Cataract and Congenital Cataract, sponsored by Eye & ENT Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment
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.
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's enrollment of 236 is above the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.
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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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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
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
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.
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.
BCVA at 3 years after surgery
Time frame: 3 years after surgery
UDVA
Time frame: Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years.
CDVA
Time frame: Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
IOP
Time frame: Postoperative day 1, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
Axial length
Time frame: Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
stereopsis
Time frame: Postoperative 6 months, 1 year, 2 years, and 3 years
residual astigmatism
Time frame: Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years
Corneal astigmatism
Time frame: Postoperative 1month, 3 months, 6 months, 1 year, 2 years, and 3 years.
spherical equivalent
Time frame: Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years.
IOL rotation
Time frame: Postoperative 1 week, 2 weeks, and 1 month.
Plan to share: Undecided
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Eye & ENT Hospital of Fudan University