Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-06-26 @ 5:09 AM
Study NCT ID:
NCT02908633
Status:
UNKNOWN
Last Update Posted:
2016-09-21
First Post:
2016-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens 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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-17', 'studyFirstSubmitDate': '2016-09-17', 'studyFirstSubmitQcDate': '2016-09-17', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean IOP', 'timeFrame': 'change form baseline at 24 months'}, {'measure': 'Number of antiglaucoma drugs', 'timeFrame': 'change from baseline at 24 months'}, {'measure': 'intraoperative complications', 'timeFrame': 'at the day of surgery'}], 'secondaryOutcomes': [{'measure': 'Best-Corrected Visual Acuity', 'timeFrame': 'change from baseline at 24 months'}, {'measure': 'Visual Field changes', 'timeFrame': 'change from baseline at 24 months', 'description': 'MD,'}, {'measure': 'Early and Late postsurgical complications', 'timeFrame': 'within 24 months'}, {'measure': '% IOP reduction', 'timeFrame': 'change at 24 months from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['open angle glaucoma', 'canaloplasty', 'migs', 'abic'], 'conditions': ['Primary Open Angle Glaucoma, Cataract']}, 'referencesModule': {'references': [{'pmid': '31377849', 'type': 'DERIVED', 'citation': 'Danielewska ME, Kicinska AK, Placek MM, Lewczuk K, Rekas M. Changes in spectral parameters of corneal pulse following canaloplasty. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2449-2459. doi: 10.1007/s00417-019-04433-9. Epub 2019 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* co-existing glaucoma and cataract\n* glaucoma types: primary open angle glaucoma,\n* eye with characteristic glaucoma changes (biomicroscopic,visual field)\n* IOP over 21 mmHg after washout\n* patients not tolerating antiglaucoma medications,\n* patients with poor compliance\n* progression in visual field\n\nExclusion Criteria:\n\n* previous surgical glaucoma procedure\n* previous cataract surgery\n* BCVA under 0,004\n* closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary)\n* poorly controlled diabetes mellitus\n* advanced AMD\n* active inflammatory disease\n* pregnancy\n* mental disease or emotional instability general steroid therapy'}, 'identificationModule': {'nctId': 'NCT02908633', 'briefTitle': 'Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Comparison of Safety and Efficacy of Three Variants of Canaloplasty: Ab-externo, Ab-interno and Minicanaloplasty Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.', 'orgStudyIdInfo': {'id': '76/WIM/2015'}, 'secondaryIdInfos': [{'id': '76/WIM/015', 'type': 'OTHER', 'domain': 'MMI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'canaloplasty ab externo and phacoemulsification', 'description': 'As soon as the two scleral flaps: deep and superficial -similar to deep sclerectomy are dissected, the phacoemulsification with PCIOL insertion is performed. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and guided for 360 degrees within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. Then a suture is tied to the distal tip and the microcatheter is withdrawn. As it appears at the other ostium of canal the microcatheter it separated from the suture.Then suture loop is tightened to tension the trabecular meshwork. The superficial flap is sutured watertight to prevent bleb formation', 'interventionNames': ['Procedure: canaloplasty and phacoemulsification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'canaloplasty ab interno and phacoemulsification', 'description': "This variant of canaloplasty spares conjunctival surface. First phacoemulsification and PCIOL placement is performed. The Schlemm's canal is reached through goniotomy through anterior chamber. Similarly microcatheter is inserted and viscodilatator applicated. The key difference, is that no tensioning suture is left after the catheter is withdrawn. phacoemulsification is performed.", 'interventionNames': ['Procedure: canaloplasty and phacoemulsification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'minicanaloplasty and phacoemulsification', 'description': 'The dissected conjunctival flap is of minimal size. The scleral flaps are sized: superficial flap 3x1mm, and deep flap: 1x1 mm- with no removal of the deep flap. Afterwards phacoemulsification part is performed. The microcatheterization and viscodilatation are conducted as in the traditional procedure.The conjunctiva is closed with one suture or coagulation', 'interventionNames': ['Procedure: canaloplasty and phacoemulsification']}], 'interventions': [{'name': 'canaloplasty and phacoemulsification', 'type': 'PROCEDURE', 'otherNames': ['canaloplasty ab externo', 'canaloplasty ab interno', 'minicanaloplasty'], 'armGroupLabels': ['canaloplasty ab externo and phacoemulsification', 'canaloplasty ab interno and phacoemulsification', 'minicanaloplasty and phacoemulsification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Military Institute of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Marek Rękas, MD, PhD, Professor', 'role': 'CONTACT', 'email': 'rekaspl@gmail.com', 'phone': '+48604113659'}, {'name': 'Aleksandra Kicińska, MD', 'role': 'CONTACT', 'email': 'aleksandra.kicinska@gmail.com', 'phone': '+48601339376'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD Professor of Ophthalmology', 'investigatorFullName': 'Marek Rekas', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}