Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT06294795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2024-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toric Intraocular Lens Implantation in Pediatric Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity', 'timeFrame': 'recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)', 'description': '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'}, {'measure': 'Uncorrected (UCNVA) and corrected (CNVA) near visual acuity', 'timeFrame': 'recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)', 'description': 'measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient\\&#39;s age'}, {'measure': 'Refraction measurements', 'timeFrame': 'recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)', 'description': 'obtained with KR-1W Wavefront Analyzer'}], 'secondaryOutcomes': [{'measure': 'Keratometry measurements', 'timeFrame': 'recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)', 'description': 'obtained with KR-1W Wavefront Analyzer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract Congenital', 'Astigmatism', 'Toric IOL'], 'conditions': ['Cataract Congenital', 'Astigmatism', 'IOL']}, 'descriptionModule': {'briefSummary': 'To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism', 'detailedDescription': 'This single-center, single-blinded, prospective, randomized controlled trial was performed at two sites of Kazakh Eye Research Institute.\n\nChildren 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Visually significant cataract;\n2. Corneal astigmatism more than 1.25 diopters;\n3. Children aged ≥ 6 years and \\< 18 years.\n\nExclusion criteria:\n\n1. Patients with a corneal diameter less than 9 mm;\n2. Presence of corneal scarring;\n3. Irregular astigmatism;\n4. Intraocular pressure more than 25 mm Hg;\n5. Active inflammatory process of the eyeball or signs of a previous episode of inflammation;\n6. Traumatic, subluxated, or complicated cataract;\n7. Persistent Fetal Vasculature;\n8. Diseases of the optic nerve or macula that may limit visual potential;\n9. History of previous intraocular surgeries;\n10. Performing posterior capsulorhexis intraoperatively.'}, 'identificationModule': {'nctId': 'NCT06294795', 'acronym': 'TILIPC', 'briefTitle': 'Toric Intraocular Lens Implantation in Pediatric Cataract', 'organization': {'class': 'NETWORK', 'fullName': 'Kazakh Eye Research Institute'}, 'officialTitle': 'A Prospective Randomized Controlled Trial of Toric Intraocular Lens Implantation in Pediatric Cataractous Eyes', 'orgStudyIdInfo': {'id': '02-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toric', 'description': 'A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx', 'interventionNames': ['Procedure: congenital/pediatric cataract surgery', 'Device: Toric IOLs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-toric', 'description': 'A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF', 'interventionNames': ['Procedure: congenital/pediatric cataract surgery', 'Device: Non-Toric IOLs']}], 'interventions': [{'name': 'congenital/pediatric cataract surgery', 'type': 'PROCEDURE', 'otherNames': ['phacoaspiration'], 'description': "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.", 'armGroupLabels': ['Non-toric', 'Toric']}, {'name': 'Non-Toric IOLs', 'type': 'DEVICE', 'otherNames': ['Models SN60WF and SY60WF'], 'description': 'A folding hydrophobic acrylic IOLs AcrySof IQ SN60WF and Clareon SY60WF for the non-toric group (Alcon Laboratories, Inc.) ARE implanted.', 'armGroupLabels': ['Non-toric']}, {'name': 'Toric IOLs', 'type': 'DEVICE', 'otherNames': ['Models CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8'], 'description': 'A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx for the toric group (Alcon Laboratories, Inc.) were implanted.', 'armGroupLabels': ['Toric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050012', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Kazakh Eye Research Institute', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Kazakh Eye Research Institute', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}], 'overallOfficials': [{'name': 'Kairat Ruslanuly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kazakh Eye Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kazakh Eye Research Institute', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'a researcher, a vitreoretinal surgeon', 'investigatorFullName': 'Kairat Ruslanuly', 'investigatorAffiliation': 'Kazakh Eye Research Institute'}}}}