Toric Intraocular Lens Implantation in Pediatric Cataract

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 6 to 18 years
• All sexes
• No healthy volunteers
• Child, Adult

Trial locations and contacts

2 sites in 1 country.

About this study

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

Conditions

Cataract Congenital, Astigmatism, IOL

Being tested

congenital/pediatric cataract surgery, Non-Toric IOLs, Toric IOLs

Keywords

Cataract Congenital, Astigmatism, Toric IOL

Medical subject headings

Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• congenital/pediatric cataract surgeryProcedure or surgery

  Also called phacoaspiration

  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.

• Non-Toric IOLsDevice

  Also called Models SN60WF and SY60WF

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

• Toric IOLsDevice

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

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

2. 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

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

3. Refraction measurements

   obtained with KR-1W Wavefront Analyzer

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Mar 2024
2. Study start1 Mar 2024
3. Primary completion5 Feb 2025
4. Study completion16 Mar 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Cataract CongenitalStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.