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CompletedNCT06294795TILIPCUpdated Oct 16, 2026

Toric Intraocular Lens Implantation in Pediatric Cataract

An interventional study of congenital/pediatric cataract surgery and Non-Toric IOLs in Cataract Congenital, Astigmatism and IOL, sponsored by Kazakh Eye Research Institute. Completed at 2 sites in Kazakhstan. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Kazakh Eye Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

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

Read the 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 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.

02

Conditions studied

  • Cataract Congenital
  • Astigmatism
  • IOL

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Keywords

  • Cataract Congenital
  • Astigmatism
  • Toric IOL
03

In context

Astigmatism

417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.

This study's enrollment of 40 is below the median of 55 across 325 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Kazakh Eye Research Institute is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Toric

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

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

  • Active comparator
    Non-toric

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

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

Interventions

  • Procedurecongenital/pediatric cataract surgery

    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.

    Also known as: phacoaspiration

  • DeviceNon-Toric IOLs

    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

  • DeviceToric IOLs

    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

06

What researchers measure

Primary outcomes

  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\&amp;amp;#39;s age

    Time frame: 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\&amp;#39;s age

    Time frame: 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

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

Secondary outcomes

  1. Keratometry measurements

    obtained with KR-1W Wavefront Analyzer

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

07

Study locations

2 sites
  • Kazakh Eye Research Institute
    Almaty, 050012, Kazakhstan
  • Kazakh Eye Research Institute
    Astana, 010000, Kazakhstan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Feb 2025, 11 months.

Of 77 non-industry interventional studies with no phase under Astigmatism, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 11 months is below that.

Counting every sponsor, half of 183 studies reached it within 12 months; a quarter within 4 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2024
First posted
Mar 6, 2024
StartActual
Mar 1, 2024
Primary completionActual
Feb 5, 2025
CompletionActual
Mar 16, 2026
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06294795
Lead sponsor
Kazakh Eye Research Institute
Responsible party
Kairat Ruslanuly (a researcher, a vitreoretinal surgeon, Kazakh Eye Research Institute) — Principal investigator
First posted
Mar 6, 2024
Start date
Mar 1, 2024
Primary completion
Feb 5, 2025
Completion
Mar 16, 2026
Last update
Oct 16, 2026

Study contacts

Kairat Ruslanuly, MD
principal investigator · Kazakh Eye Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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