Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-01-19 @ 9:13 PM
Study NCT ID:
NCT02558218
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery
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': 'C022030', 'term': 'methylacetylene'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foreign body sensation', 'timeFrame': '1 month postoperatively', 'description': 'Foreign body sensation will be assessed by a direct 5-scale, Likert type question that will be addressed to the participants at the 30th postoperative day'}], 'secondaryOutcomes': [{'measure': 'Ocular Redness', 'timeFrame': '7 days postoperatively', 'description': 'Ocular redness will be assessed by means of a validated photographic chart'}, {'measure': 'Corneal Sensitivity', 'timeFrame': '1 month postoperatively', 'description': 'Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '28497070', 'type': 'DERIVED', 'citation': 'Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': "Primary objective of the study is the assessment of the patients' discomfort and ocular redness following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.", 'detailedDescription': 'Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group (who will receive Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale\n\nExclusion Criteria:\n\n1. Endothelial cell count less than 1900,\n2. Glaucoma,\n3. IOP-lowering medications,\n4. Former incisional surgery,\n5. Former diagnosis of corneal disease,\n6. Diabetes or autoimmune diseases\n7. Former diagnosis of dry eye disease'}, 'identificationModule': {'nctId': 'NCT02558218', 'briefTitle': 'Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation', 'orgStudyIdInfo': {'id': 'FBCat'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Systane ultra group', 'description': 'Participants in this group were administered systane ultra quid (Alcon, Fort Worth) for two months postoperatively), additionally to tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.', 'interventionNames': ['Drug: Systane Ultra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants in this group were administered the standard postoperative medication \\[tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.\\]', 'interventionNames': ['Drug: tobradex quid (Standard)']}], 'interventions': [{'name': 'Systane Ultra', 'type': 'DRUG', 'otherNames': ['Administration of Systane Ultra (Alcon)'], 'description': 'Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months', 'armGroupLabels': ['Systane ultra group']}, {'name': 'tobradex quid (Standard)', 'type': 'DRUG', 'otherNames': ['Standard Medication'], 'description': 'Standard medication (tobradex quid for 20 days)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'facility': 'Eye Institute Of thrace', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'overallOfficials': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}