Cataract CongenitalTILIPCNCT06294795
Toric Intraocular Lens Implantation in Pediatric Cataract
A study testing congenital/pediatric cataract surgery, Non-Toric IOLs and Toric IOLs in people with Cataract Congenital and Astigmatism, run by Kazakh Eye Research Institute at 2 sites in Kazakhstan.
Trial summary
To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cataract Congenital, Astigmatism, IOL
- What is being tested?
- congenital/pediatric cataract surgery, Non-Toric IOLs and Toric IOLs
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 1 Mar 2024to 16 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Visually significant cataract;
- Corneal astigmatism more than 1.25 diopters;
- Children aged ≥ 6 years and < 18 years.
Who cannot join
- 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;
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- Persistent Fetal Vasculature;
- Diseases of the optic nerve or macula that may limit visual potential;
- History of previous intraocular surgeries;
- Performing posterior capsulorhexis intraoperatively.
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites
Kazakh Eye Research Institute
Almaty, 050012
Kazakh Eye Research Institute
Astana, 010000
About this study
Official title: 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
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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Toric | Experimental | A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx Receives: Procedure: congenital/pediatric cataract surgery; Device: Toric IOLs |
| Non-toric | Active comparator | A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF Receives: Procedure: congenital/pediatric cataract surgery; Device: Non-Toric IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;#39;s age
Measured: 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
measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient\&#39;s age
Measured: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
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)
Secondary outcomes (1)
Keratometry 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.
- First posted6 Mar 2024
- Study start1 Mar 2024
- Primary completion5 Feb 2025
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakh Eye Research Institute
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Kairat Ruslanuly, Kazakh Eye Research Institute
- Investigators
- Kairat Ruslanuly, MD, Principal investigator, Kazakh Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294795
- Sponsor's protocol ID
- 02-2024
- Acronym
- TILIPC
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Toric Intraocular Lens Implantation in Pediatric Cataractous Eyes
- ClinicalTrials.gov ID
- NCT06294795
- Acronym / sponsor ID
- TILIPC / 02-2024
- Conditions
- Cataract Congenital, Astigmatism, IOL
- Keywords
- Cataract Congenital, Astigmatism, Toric IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kazakh Eye Research InstituteResearch network
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric | Experimental | Procedure: congenital/pediatric cataract surgery, Device: Toric IOLsA folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx |
| Non-toric | Active comparator | Procedure: congenital/pediatric cataract surgery, Device: Non-Toric IOLsA folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Visually significant cataract;
- Corneal astigmatism more than 1.25 diopters;
- Children aged ≥ 6 years and < 18 years.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| congenital/pediatric cataract surgeryAlso: phacoaspirationAll 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. | Procedure or surgery | Non-toric, Toric |
| Non-Toric IOLsAlso: Models SN60WF and SY60WFA folding hydrophobic acrylic IOLs AcrySof IQ SN60WF and Clareon SY60WF for the non-toric group (Alcon Laboratories, Inc.) ARE implanted. | Device | Non-toric |
| Toric IOLsAlso: Models CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx for the toric group (Alcon Laboratories, Inc.) were implanted. | Device | Toric |
Primary outcome
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;#39;s age
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\&#39;s age
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
1 secondary outcome
Keratometry measurements
Time frame: recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kairat Ruslanuly, MD principal investigator
Kazakh Eye Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing congenital/pediatric cataract surgery, Non-Toric IOLs and Toric IOLs in people with Cataract Congenital and Astigmatism, run by Kazakh Eye Research Institute at 2 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.