Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-25 @ 11:52 AM
Study NCT ID:
NCT03390361
Status:
COMPLETED
Last Update Posted:
2018-01-05
First Post:
2017-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before the surgery.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "Patients' eyes will be randomized into two groups receiving either MCS or LCS. In the LCS group aqueous humour will be collected exactly five minutes after laser pretreatment. In the MCS group aqueous humour will be collected before manual manipulation of anterior chamber. Aqueous humour will be screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-04', 'studyFirstSubmitDate': '2017-12-28', 'studyFirstSubmitQcDate': '2018-01-03', 'lastUpdatePostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proinflammatory cytokines (IL-1β, IL-6) and total-PG', 'timeFrame': '5 minutes after laser procedure', 'description': 'Interleukin IL-1β, Interleukin IL-6, total-prostaglandin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laser Cataract Surgery', 'Prostaglandin'], 'conditions': ['Age Related Cataracts']}, 'descriptionModule': {'briefSummary': 'Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system.\n\nAfter surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation.\n* Pupil dilation of ≥ 6.5mm\n* Age 40 and older\n\nExclusion Criteria:\n\n* Corneal abnormality\n* Pseudoexfoliation\n* Preceding ocular surgery or trauma\n* Uncontrolled glaucoma\n* Proliferative diabetic retinopathy\n* Iris neovascularization\n* History of uveitis/iritis\n* Microphthalmus\n* Recurrent intraocular inflammation of unknown etiology\n* Blind fellow eye\n* Uncontrolled systemic or ocular disease\n* Pregnancy\n* Lactation'}, 'identificationModule': {'nctId': 'NCT03390361', 'briefTitle': 'Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Intraindividual Comparison of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device Compared to Manual Cataract Surgery', 'orgStudyIdInfo': {'id': 'Femto IL + PG Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LCS', 'description': 'Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius.', 'interventionNames': ['Device: Femtosecond Laser-assisted']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MCS', 'description': 'Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts.', 'interventionNames': ['Procedure: Manual Cataract Surgery']}], 'interventions': [{'name': 'Femtosecond Laser-assisted', 'type': 'DEVICE', 'description': 'Laser cataract surgery will be performed in one eye', 'armGroupLabels': ['LCS']}, {'name': 'Manual Cataract Surgery', 'type': 'PROCEDURE', 'description': 'Manual cataract surgery will be performed in contralateral eye', 'armGroupLabels': ['MCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Rupert Menapace, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Rupert Menapace', 'investigatorAffiliation': 'Medical University of Vienna'}}}}