Toric Intraocular Lens Implantation in Pediatric Cataract

Astigmatism Clinical Trial

— TILIPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294795
• Other study ID #: 2-2024
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Kazakh Eye Research Institute
• Contact: Kairat Ruslanuly, MD
• Phone: +77019008387
• Email: ruslanuly.kairat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• IOL

Intervention

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). ?ortical 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.

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

Locations

Country	Name	City	State
Kazakhstan	Kazakh Eye Research Institute	Almaty
Kazakhstan	Kazakh Eye Research Institute	Astana

Sponsors (1)

Lead Sponsor	Collaborator
Kazakh Eye Research Institute

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity	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)
Primary	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)
Primary	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	Keratometry 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)