Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 5:18 PM
Study NCT ID:
NCT02049333
Status:
COMPLETED
Last Update Posted:
2014-01-30
First Post:
2014-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-29', 'studyFirstSubmitDate': '2014-01-27', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intra- and post-operative complications', 'timeFrame': 'Up to one year after surgery', 'description': 'Analyzing any unexpected complications from the surgery such as prolonged hypotony, intraocular pressure spike, prolonged corneal inflammation etc. This will be done during the clinic visit and analyzed under slit lamp examination.'}], 'primaryOutcomes': [{'measure': 'Anterior Chamber Angle Depth (nasal angle)', 'timeFrame': 'Twelve months', 'description': 'Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging'}], 'secondaryOutcomes': [{'measure': 'Number of glaucoma medications', 'timeFrame': 'Twelve months post-op', 'description': 'The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.'}, {'measure': 'Intraocular pressure (IOP)', 'timeFrame': 'Twelve months post-op', 'description': 'IOP will be recorded and compared to pre-operative IOP.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has to be ≥ 18 years of age of either gender\n* Nuclear sclerotic cataract graded by LOCS III to be \\< 5\n* Diagnosis of Plateau Iris Configuration or Syndrome\n* No contraindication for cataract or ECPL operation\n* Written informed consent on IRB approved Informed Consent Form\n\nExclusion Criteria:\n\n* Hard cataracts, LOCS III 5 and 6\n* Ciliary body cysts\n* Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.)\n* Congenital anomaly of the irido-trabecular angle\n* Previous intraocular surgery\n* Previous laser gonioplasty to either eye\n* Placement of the intraocular lens in any place other than the capsular bag\n* Pupilloplasty\n* Rubeosis\n* Peripheral anterior synechiae (PAS) nasal angle and/or \\>180 degrees of PAS\n* Neovascular glaucoma; or glaucoma associated with vascular ischemic disorders\n* Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)\n* Corneal opacities or disorders that would inhibit visualization of the nasal angle\n* Chronic ocular inflammatory disease or presence of active ocular inflammation with risk for synechial/proliferative changes\n* Inability to attend regular follow-up assessment or to give informed written consent.'}, 'identificationModule': {'nctId': 'NCT02049333', 'briefTitle': 'Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Credit Valley EyeCare'}, 'officialTitle': 'Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study', 'orgStudyIdInfo': {'id': 'ECPLateau10.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phacoemulsification', 'description': 'Cataract extraction alone', 'interventionNames': ['Procedure: Phacoemulsification']}, {'type': 'EXPERIMENTAL', 'label': 'Phacoemulsification with Endoscopic Cycloplasty (ECPL)', 'description': 'Cataract extraction combined with endoscopic cycloplasty', 'interventionNames': ['Procedure: Phacoemulsification', 'Procedure: Endoscopic Cycloplasty (ECPL)']}], 'interventions': [{'name': 'Phacoemulsification', 'type': 'PROCEDURE', 'armGroupLabels': ['Phacoemulsification', 'Phacoemulsification with Endoscopic Cycloplasty (ECPL)']}, {'name': 'Endoscopic Cycloplasty (ECPL)', 'type': 'PROCEDURE', 'armGroupLabels': ['Phacoemulsification with Endoscopic Cycloplasty (ECPL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6V 1B4', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Osler EyeCare', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L5L 1W8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley EyeCare', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'Ike K Ahmed, MD FRCSC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Toronto, Toronto, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Credit Valley EyeCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Iqbal Ike Ahmed', 'investigatorAffiliation': 'Credit Valley EyeCare'}}}}