Toric Intraocular Lens Implantation in Pediatric Cataract (TILIPC)

March 12, 2024 updated by: Kairat Ruslanuly, Kazakh Eye Research Institute

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 IOLs 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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 050012
        • Recruiting
        • Kazakh Eye Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lukpan Orazbekov, MD
        • Sub-Investigator:
          • Kairat Ruslanuly, MD
        • Sub-Investigator:
          • Zhansaya Sultanbayeva, MD
        • Sub-Investigator:
          • Meruert Ashimova, MD
      • Astana, Kazakhstan, 010000
        • Recruiting
        • Kazakh Eye Research Institute
        • Contact:
        • Contact:
          • Asiya Beisebayeva, MD
          • Phone Number: +77018333953
        • Principal Investigator:
          • Aigerim Tuletova, MD
        • Sub-Investigator:
          • Asiya Beisebayeva, MD
        • Sub-Investigator:
          • Gulnaz Kassymbekova, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toric
A folding hydrophobic acrylic IOLs AcrySof IQ SN60WF and Clareon SY60WF
Device: Toric IOLs
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
Procedure: congenital/pediatric cataract surgery
All procedures are performed under general anesthesia according to the standard technique of congenital/pediatric cataract surgery with an 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.
Other Names:
  • phacoaspiration
Active Comparator: Non-toric
A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx
Device: Non-Toric IOLs
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
Procedure: congenital/pediatric cataract surgery
All procedures are performed under general anesthesia according to the standard technique of congenital/pediatric cataract surgery with an 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.
Other Names:
  • phacoaspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
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's age
recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
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
recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kazakh Eye Research Institute

Investigators

  • Principal Investigator: Lukpan Orazbekov, MD, Kazakh Eye Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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