Toric Intraocular Lens Implantation in Pediatric Cataract

NCT06294795 | Completed DMC

• 1 other identifier: 02-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism

Conditions

Astigmatism; IOL; Cataract Congenital

Keywords

Cataract Congenital; Astigmatism; Toric IOL

Outcome Measures

Primary Outcomes (3)

• Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity

  measured using the Lea symbol visual acuity chart or the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart according to the patient\'s age

  recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)

• Uncorrected (UCNVA) and corrected (CNVA) near visual acuity

  measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient\'s age

  recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)

• Refraction measurements

  obtained with KR-1W Wavefront Analyzer

  recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)

Secondary Outcomes (1)

• Keratometry measurements

  recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)

Study Arms (2)

Toric

EXPERIMENTAL

A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx

Procedure: congenital/pediatric cataract surgery; Device: Toric IOLs

Non-toric

ACTIVE COMPARATOR

A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF

Procedure: congenital/pediatric cataract surgery; Device: Non-Toric IOLs

Interventions

Non-Toric IOLs DEVICE

A folding hydrophobic acrylic IOLs AcrySof IQ SN60WF and Clareon SY60WF for the non-toric group (Alcon Laboratories, Inc.) ARE implanted.

Also known as: Models SN60WF and SY60WF

Non-toric

Toric IOLs DEVICE

A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx for the toric group (Alcon Laboratories, Inc.) were implanted.

Also known as: Models CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8

Toric

congenital/pediatric cataract surgery PROCEDURE

All procedures are performed under general anesthesia according to the standard technique of congenital/pediatric cataract surgery with an intraocular lens (IOL) implantation. Paracentesis is performed at 2.30 o\'clock using a 20-gauge straight microvitreoretinal (MVR) knife; a high molecular weight ophthalmic viscosurgical devices (OVD) is injected into the anterior chamber. Then a 2.4 mm corneal tunnel incision is made at 11 o'clock with a disposable keratome knife 2.2 mm. Circular continuous capsulorhexis (≈ 5.5 mm). Сortical cleaving hydrodissection is followed by bimanual phacoaspiration in irrigation-aspiration mode. OVD is injected in the anterior chamber and an IOL is implanted in the capsular bag. Residual OVD is aspirated from the anterior chamber and behind the IOL and followed by IOL alignment. The surgery is completed with corneal hydration at the tunnel incision site.

Also known as: phacoaspiration

Non-toric; Toric

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kazakh Eye Research Institute: lead

Study Sites (2)

Kazakh Eye Research Institute

Almaty, 050012, Kazakhstan

Location

Kazakh Eye Research Institute

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Kairat Ruslanuly, MD

  Kazakh Eye Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: a researcher, a vitreoretinal surgeon

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion: February 5, 2025
• Study Completion: March 16, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

KA (2)