A Prospective Randomized Controlled Trial of Toric Intraocular Lens Implantation in Pediatric Cataractous Eyes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity
Study Overview
Brief Summary
To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism
Detailed Description
This single-center, single-blinded, prospective, randomized controlled trial was performed at two sites of Kazakh Eye Research Institute.
Children with pediatric cataract and corneal astigmatism were included and randomized to two groups for pediatric cataract surgery with toric and non-toric intraocular lens (IOL) implantation. The uncorrected and corrected distance visual acuity, near visual acuity, keratometry data, and residual astigmatism were evaluated.
The purpose of this study is to evaluate the visual and refractive outcomes after a toric IOL implantation in pediatric eyes with cataract and preexisting corneal astigmatism.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Visually significant cataract;
- •Corneal astigmatism more than 1.25 diopters;
- •Children aged ≥ 6 years and < 18 years.
Exclusion Criteria
- •Patients with a corneal diameter less than 9 mm;
- •Presence of corneal scarring;
- •Irregular astigmatism;
- •Intraocular pressure more than 25 mm Hg;
- •Active inflammatory process of the eyeball or signs of a previous episode of inflammation;
- •Traumatic, subluxated, or complicated cataract;
- •Persistent Fetal Vasculature;
- •Diseases of the optic nerve or macula that may limit visual potential;
- •History of previous intraocular surgeries;
- •Performing posterior capsulorhexis intraoperatively.
Arms & Interventions
Toric
A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx
Intervention: congenital/pediatric cataract surgery (Procedure)
Toric
A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx
Intervention: Toric IOLs (Device)
Non-toric
A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF
Intervention: congenital/pediatric cataract surgery (Procedure)
Non-toric
A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF
Intervention: Non-Toric IOLs (Device)
Outcomes
Primary Outcomes
Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity
Time Frame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
measured using the Lea symbol visual acuity chart or the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart according to the patient\&amp;#39;s age
Uncorrected (UCNVA) and corrected (CNVA) near visual acuity
Time Frame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient\&#39;s age
Refraction measurements
Time Frame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
obtained with KR-1W Wavefront Analyzer
Secondary Outcomes
- Keratometry measurements(recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year))
Investigators
Kairat Ruslanuly
a researcher, a vitreoretinal surgeon
Kazakh Eye Research Institute