Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-04-17 @ 10:09 PM
Study NCT ID:
NCT02975895
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Different IOLs in Patients With and Without Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D002386', 'term': 'Cataract'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inflammatory response', 'timeFrame': 'Preoperatively and at seven occasions within two years postoperatively'}], 'secondaryOutcomes': [{'measure': 'Evaluation of posterior capsule opacification after six months', 'timeFrame': 'Six months (plus or minus 30 days) postoperatively'}, {'measure': 'Evaluation of posterior capsule opacification after one year', 'timeFrame': 'One year (plus or minus 30 days) postoperatively'}, {'measure': 'Evaluation of posterior capsule opacification after two years', 'timeFrame': 'Two years (plus or minus 2 months) postoperatively'}, {'measure': 'Change in best corrected visual acuity assessed in decimal using Snellen charts', 'timeFrame': 'Preoperatively and at six occasions within two years postoperatively'}, {'measure': 'Complications', 'timeFrame': 'Preoperatively and at seven occasions within two years postoperatively', 'description': 'Postoperative glaucoma or cystoid macular edema'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uveitis', 'Cataract', 'Inflammation', 'Posterior Capsule Opacification']}, 'descriptionModule': {'briefSummary': 'Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties.\n\nUveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this disease have an increased risk of developing cataract due to the inflammation itself and treatment with steroids. They also have an increased risk of complications during surgery and postoperatively. In this group the selection of IOL might be of greater importance.\n\nThe aim of this prospective randomized controlled study is to compare the outcome of hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataract requiring surgery\n* Ability to understand and sign consent form\n\nExclusion Criteria:\n\n* Extensive corneal scarring\n* Other eye surgery less than 3 months before inclusion\n* Unregulated glaucoma\n* Active uveitis (increased inflammation and treatment less than 3 months before inclusion)\n* Intraoperative complications (capsular tear or vitreous loss)'}, 'identificationModule': {'nctId': 'NCT02975895', 'briefTitle': 'Outcome of Different IOLs in Patients With and Without Uveitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis', 'orgStudyIdInfo': {'id': '031-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hydrophobic IOL: Vivinex (HOYA)', 'description': 'Intraocular lens with hydrophobic properties: Vivinex (HOYA).', 'interventionNames': ['Device: Hydrophobic IOL: Vivinex (HOYA)']}, {'type': 'OTHER', 'label': 'Hydrophilic IOL: INCISE (Bausch+Lomb)', 'description': 'Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).', 'interventionNames': ['Device: Hydrophilic IOL: INCISE (Bausch+Lomb)']}], 'interventions': [{'name': 'Hydrophobic IOL: Vivinex (HOYA)', 'type': 'DEVICE', 'description': 'Patients requiring cataract surgery will be randomized to one of the two types of IOLs.', 'armGroupLabels': ['Hydrophobic IOL: Vivinex (HOYA)']}, {'name': 'Hydrophilic IOL: INCISE (Bausch+Lomb)', 'type': 'DEVICE', 'description': 'Patients requiring cataract surgery will be randomized to one of the two types of IOLs.', 'armGroupLabels': ['Hydrophilic IOL: INCISE (Bausch+Lomb)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mölndal', 'country': 'Sweden', 'facility': 'Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}], 'overallOfficials': [{'name': 'Madeleine Zetterberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}