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Completed

NCT Number: NCT06294795

Toric Intraocular Lens Implantation in Pediatric Cataract

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

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Key information

Conditions

Cataract Congenital Astigmatism Eye Diseases IOL Refractive Errors

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kazakh Eye Research Institute, Almaty, Kazakhstan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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&#39;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.

Other names: phacoaspiration

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.

Other names: Models SN60WF and SY60WF

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.

Other names: Models CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8

Primary outcomes

  1. 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;amp;#39;s age

  2. 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&amp;#39;s age

  3. 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

  1. Keratometry 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

Sponsors and collaborators

Lead sponsor

Kazakh Eye Research Institute

Network

Registry information

Official study title

A Prospective Randomized Controlled Trial of Toric Intraocular Lens Implantation in Pediatric Cataractous Eyes

Acronym: TILIPC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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