Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 11:57 AM
Study NCT ID:
NCT05136950
Status:
RECRUITING
Last Update Posted:
2022-01-11
First Post:
2021-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2033-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2021-11-01', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of glaucoma-related adverse events', 'timeFrame': 'One year after surgery', 'description': 'The assessment of glaucoma-related adverse events is performed at one year after surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of glaucoma-related adverse events', 'timeFrame': 'Six months,three years, five years, ten years after surgery', 'description': 'The assessment of glaucoma-related AEs is performed at six months, three years, five years, ten years after surgery'}, {'measure': 'Visual acuity', 'timeFrame': 'Six months,one year, three years, five years, ten years after surgery', 'description': 'Evaluated with an ETDRS chart. For those who are unable to use ETDRS chart, visual acuity will be evaluated with Lea Symbol Chart or Teller Acuity Cards'}, {'measure': 'Ocular refractive power', 'timeFrame': 'Six months,one year,three years, five years, ten years after surgery', 'description': 'Measured by the Auto Refractometer'}, {'measure': 'Intraocular lens decentration', 'timeFrame': 'Six months,one year, three years, five years, ten years after surgery', 'description': 'Measured by anterior segment scanning'}, {'measure': 'Intraocular lens tilt', 'timeFrame': 'Six months,one year, three years, five years, ten years after surgery', 'description': 'Measured by anterior segment scanning'}, {'measure': 'Incidence of other adverse events', 'timeFrame': 'Six months,one year, three years, five years, ten years after surgery', 'description': 'The assessment of other adverse events will be performed at six months,one year,three years, five years, ten years after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric aphakia', 'Secondary Intraocular Lens Implantation', 'Glaucoma-related Adverse Events', 'In-the-bag IOL implantation', 'Sulcus IOL fixation'], 'conditions': ['Lens Implantation, Intraocular']}, 'referencesModule': {'references': [{'pmid': '34653355', 'type': 'RESULT', 'citation': 'Liu Z, Lin H, Jin G, Tan X, Qu B, Jin L, Chen X, Wang W, Han X, Xu J, Ying G, Han Y, He M, Congdon N, Chen W, Luo L, Liu Y. In-the-Bag Versus Ciliary Sulcus Secondary Intraocular Lens Implantation for Pediatric Aphakia: A Prospective Comparative Study. Am J Ophthalmol. 2022 Apr;236:183-192. doi: 10.1016/j.ajo.2021.10.006. Epub 2021 Oct 13.'}, {'pmid': '27367747', 'type': 'RESULT', 'citation': 'Wood KS, Tadros D, Trivedi RH, Wilson ME. Secondary intraocular lens implantation following infantile cataract surgery: intraoperative indications, postoperative outcomes. Eye (Lond). 2016 Sep;30(9):1182-6. doi: 10.1038/eye.2016.131. Epub 2016 Jul 1.'}, {'pmid': '33331850', 'type': 'RESULT', 'citation': 'Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.'}, {'pmid': '25579641', 'type': 'RESULT', 'citation': 'Shenoy BH, Mittal V, Gupta A, Sachdeva V, Kekunnaya R. Complications and visual outcomes after secondary intraocular lens implantation in children. Am J Ophthalmol. 2015 Apr;159(4):720-6. doi: 10.1016/j.ajo.2015.01.002. Epub 2015 Jan 9.'}, {'pmid': '28301497', 'type': 'RESULT', 'citation': 'Zhao YE, Gong XH, Zhu XN, Li HM, Tu MJ, Coursey TG, Pflugfelder SC, Gu F, Chen D. Long-term outcomes of ciliary sulcus versus capsular bag fixation of intraocular lenses in children: An ultrasound biomicroscopy study. PLoS One. 2017 Mar 16;12(3):e0172979. doi: 10.1371/journal.pone.0172979. eCollection 2017.'}, {'pmid': '25325868', 'type': 'RESULT', 'citation': 'Whitman MC, Vanderveen DK. Complications of pediatric cataract surgery. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):414-20. doi: 10.3109/08820538.2014.959192.'}, {'pmid': '37296411', 'type': 'DERIVED', 'citation': 'Zou Y, Jin L, Qu B, Chen H, Zeng M, Li X, Liu X, Luo L, Liu Z, Liu Y. Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial. Trials. 2023 Jun 9;24(1):388. doi: 10.1186/s13063-023-07411-z.'}]}, 'descriptionModule': {'briefSummary': 'To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia', 'detailedDescription': 'Treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (AEs) after IOL implantation. The investigators aim to compare the incidence of glaucoma-related AEs of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 months and 14 years\n* Had a primary diagnosis of congenital cataract.\n* Underwent cataract extraction between the ages of 2 and 24 months\n\nExclusion Criteria:\n\n* Primary IOL implantation\n* Pre-existing ocular disease which might affect the location and outcome of secondary IOL implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma)\n* Suture fixation for secondary IOL implantation'}, 'identificationModule': {'nctId': 'NCT05136950', 'briefTitle': 'Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021KYPJ135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secondary in-the-bag IOL fixation group', 'description': 'In-the-bag IOL fixation is the experimental arm', 'interventionNames': ['Procedure: Secondary in-the-bag IOL fixation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Secondary ciliary sulcus IOL fixation group', 'description': 'Ciliary sulcus IOL fixation is the control arm', 'interventionNames': ['Procedure: Secondary ciliary sulcus IOL fixation']}], 'interventions': [{'name': 'Secondary in-the-bag IOL fixation', 'type': 'PROCEDURE', 'description': 'The experimental group with secondary IOL fixated in the capsular bag', 'armGroupLabels': ['Secondary in-the-bag IOL fixation group']}, {'name': 'Secondary ciliary sulcus IOL fixation', 'type': 'PROCEDURE', 'description': 'The control group with secondary IOL fixated in the ciliary sulcus', 'armGroupLabels': ['Secondary ciliary sulcus IOL fixation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenzhen Liu, PhD', 'role': 'CONTACT', 'email': 'liu_zhenzhen@qq.com', 'phone': '+8613570382241'}], 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhenzhen Liu, PhD', 'role': 'CONTACT', 'email': 'liu_zhenzhen@qq.com', 'phone': '+86 13570382241'}], 'overallOfficials': [{'name': 'Yizhi Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Zhongshan Ophthalmic center, Guangzhou, People's Republic of China"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}