Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02523950
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2015-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007910', 'term': 'Lenses, Intraocular'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in visual acuity measured by Snellen chart', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery'}, {'measure': 'Change from baseline in central corneal thickness measured by anterior segment OCT', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery'}, {'measure': 'Change from baseline in endothelial cell density measured by corneal specular microscopy', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in endothelial graft attachment measured by anterior segment OCT', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery'}, {'measure': 'Change from baseline in corneal transparency measured by slit-lamp microscopy', 'timeFrame': '1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cataract', 'Corneal Endothelial Keratopathy', 'Phacoemulfisication+IOL Implantation', 'Endothelial Keratopathy']}, 'referencesModule': {'references': [{'pmid': '19878827', 'type': 'BACKGROUND', 'citation': 'Wang Y, Xia Y, Zeng M, Liu X, Luo L, Chen B, Liu Y, Liu Y. Torsional ultrasound efficiency under different vacuum levels in different degrees of nuclear cataract. J Cataract Refract Surg. 2009 Nov;35(11):1941-5. doi: 10.1016/j.jcrs.2009.05.055.'}, {'pmid': '19139335', 'type': 'BACKGROUND', 'citation': 'Huang T, Wang Y, Ji J, Gao N, Chen J. Deep lamellar endothelial keratoplasty for iridocorneal endothelial syndrome in phakic eyes. Arch Ophthalmol. 2009 Jan;127(1):33-6. doi: 10.1001/archophthalmol.2008.537.'}, {'pmid': '22310081', 'type': 'BACKGROUND', 'citation': 'Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.'}, {'pmid': '19548882', 'type': 'BACKGROUND', 'citation': 'Xia Y, Liu X, Luo L, Zeng Y, Cai X, Zeng M, Liu Y. Early changes in clear cornea incision after phacoemulsification: an anterior segment optical coherence tomography study. Acta Ophthalmol. 2009 Nov;87(7):764-8. doi: 10.1111/j.1755-3768.2008.01333.x. Epub 2009 Jun 22.'}], 'seeAlsoLinks': [{'url': 'http://www.gzzoc.com', 'label': 'Zhongshan Ophthalmic Center website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and Descemet membrane endothelial keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.', 'detailedDescription': 'The prospective, randomized, controlled study involves the enrollment of cataract patients with corneal endothelial dysfunction. All the patients will be randomly assigned with equal probability to the following two groups: 1. Staged group: phacoemulsification + IOL implantation is performed individually and DMEK is performed secondarily according to the corneal status of patients. During cataract surgery, viscoelastic materials and anterior lens capsule are used to protect the compromised corneal endothelium during phacoemulsification. After phacoemulsification and removal of all the lens material, a one-piece foldable IOL is implanted into the lens capsule. 2: Combined group: phacoemulsification + IOL implantation and DMEK is performed simultaneously. Standard procedures of phacoemulsification + IOL implantation are the same as in the staged group.\n\nPatients enrolled into the study will be followed for one year and will have study visits at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after each surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects are older than 18 years.\n2. Subjects have corneal endothelial dysfunction combined with cataract.\n3. Subjects have mild to moderate cortical and/or nuclear cataract.\n4. Subjects are able and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Subjects have corneal stromal opacity and/or neovascularization.\n2. Subjects have other intraocular disease that disturbs visual rehabilitation.\n3. Subjects have corneal infection, perforation or scarring.\n4. Subjects are pregnant.\n5. Subjects have concurrent disease that could confound the response to therapy.\n6. Subjects are unlikely to comply with the protocol or likely to be lost to follow-up.\n7. Subjects have known hypersensitivity or intolerance to the proposed therapy.\n8. Subjects use concomitant therapy that affects either tear function or ocular surface integrity.\n9. Subjects have had surgical or other manipulation of the eye that could confound the outcome parameters or interfere with the mechanism of action of the proposed intervention to be studied.'}, 'identificationModule': {'nctId': 'NCT02523950', 'briefTitle': 'Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Evaluation of Staged and Combined Phacoemulsification With Intraocular Lens (IOL) Implantation and Descemet Membrane Endothelial Keratoplasty (DMEK) for Cataract Patients With Corneal Endothelial Dysfunction', 'orgStudyIdInfo': {'id': '2015MEKY047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Staged group', 'description': 'Procedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily.', 'interventionNames': ['Procedure: Staged phacoemulsification and DMEK', 'Device: Intraocular lens (IOL) implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined group', 'description': 'Procedure/Surgery: Phacoemulsification + IOL implantation and DMEK are performed simultaneously.', 'interventionNames': ['Procedure: Combined phacoemulsification and DMEK', 'Device: Intraocular lens (IOL) implantation']}], 'interventions': [{'name': 'Staged phacoemulsification and DMEK', 'type': 'PROCEDURE', 'description': 'Stage 1. Phacoemulsification is performed individually. During phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.\n\nStage 2. DMEK is performed secondarily according to the corneal status of patients.', 'armGroupLabels': ['Staged group']}, {'name': 'Combined phacoemulsification and DMEK', 'type': 'PROCEDURE', 'description': 'Routine phacoemulsification and DMEK are performed simultaneously.', 'armGroupLabels': ['Combined group']}, {'name': 'Intraocular lens (IOL) implantation', 'type': 'DEVICE', 'description': 'After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.', 'armGroupLabels': ['Combined group', 'Staged group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yujuan Wang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'yujuanwang2013@gmail.com', 'phone': '8618620717002'}, {'name': 'Yizhi Liu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yujuan Wang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'yujuanwang2013@gmail.com', 'phone': '8618620717002'}, {'name': 'Ting Huang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'thuang@vip.163.com', 'phone': '862087331540'}], 'overallOfficials': [{'name': 'Yizhi Liu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haotian Lin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Haotian Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}