Congenital Cataract, Pediatric Cataract
Conditions
Keywords
astigmatism, amblyopia, toric IOL
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.
Interventions
DEVICEToric 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.
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The data analysts and investigators who observed patient outcomes during follow-up were blinded to minimize bias
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
1) aged 3 to 8 years and diagnosed as pediatric cataract; 2) at least 2.0 D of regular corneal astigmatism. \-
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA at 3 years after surgery | 3 years after surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| UDVA | Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years. |
| Corneal astigmatism | Postoperative 1month, 3 months, 6 months, 1 year, 2 years, and 3 years. |
| spherical equivalent | Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years. |
| IOL rotation | Postoperative 1 week, 2 weeks, and 1 month. |
| residual astigmatism | Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years |
Countries
China
Outcome results
None listed