Clinical trial NCT06294795: Toric Intraocular Lens Implantation in Pediatric Cataract
Official title: A Prospective Randomized Controlled Trial of Toric Intraocular Lens Implantation in Pediatric Cataractous Eyes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract Congenital
Astigmatism
IOL
Keywords: Cataract Congenital
Astigmatism
Toric IOL
Lead sponsor: Kazakh Eye Research Institute
Sponsor class: NETWORK
First posted: 2024-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. Visually significant cataract;
2. Corneal astigmatism more than 1.25 diopters;
3. Children aged ≥ 6 years and \< 18 years.

Exclusion criteria:

1. Patients with a corneal diameter less than 9 mm;
2. Presence of corneal scarring;
3. Irregular astigmatism;
4. Intraocular pressure more than 25 mm Hg;
5. Active inflammatory process of the eyeball or signs of a previous episode of inflammation;
6. Traumatic, subluxated, or complicated cataract;
7. Persistent Fetal Vasculature;
8. Diseases of the optic nerve or macula that may limit visual potential;
9. History of previous intraocular surgeries;
10. Performing posterior capsulorhexis intraoperatively.

Primary outcomes:
measure: Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity
timeFrame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
measure: Uncorrected (UCNVA) and corrected (CNVA) near visual acuity
timeFrame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
measure: Refraction measurements
timeFrame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
Secondary outcomes:
measure: Keratometry measurements
timeFrame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh Eye Research Institute
city: Astana
country: Kazakhstan
facility: Kazakh Eye Research Institute
Study officials:
affiliation: Kazakh Eye Research Institute
name: Kairat Ruslanuly, MD
role: PRINCIPAL_INVESTIGATOR
References: