Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-23 @ 12:54 PM
Study NCT ID:
NCT02344732
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2015-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D009355', 'term': 'Neomycin'}, {'id': 'C049064', 'term': 'Maxitrol'}, {'id': 'C100236', 'term': 'homatropine'}, {'id': 'C041364', 'term': 'nitrox'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean corneal epithelial wound healing time (in days)', 'timeFrame': '1 to 7 days'}], 'secondaryOutcomes': [{'measure': 'Age of subject as a factor influencing wound healing time', 'timeFrame': '1-7 days'}, {'measure': 'Glycemic control of subject (measured by glycated hemoglobin, HbA1c)', 'timeFrame': '1-7 days'}, {'measure': 'Duration of surgery and its influence on wound healing time', 'timeFrame': '1-7 days'}, {'measure': 'Duration of diabetes mellitus (measured in years) and its influence on wound healing time', 'timeFrame': '1-7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epithelium, cornea, diabetes, vitrectomy, oxygen'], 'conditions': ['Corneal Diseases']}, 'descriptionModule': {'briefSummary': '1. To compare the corneal epithelial defect healing time between diabetic patients receiving and not receiving supplementary oxygen after vitrectomy.\n2. To determine whether factors such as age, duration of diabetes, duration of surgery and level of glycemic control have any influence on corneal epithelial wound healing time in diabetic patients receiving and not receiving supplementary oxygen post-vitrectomy.', 'detailedDescription': 'This study aims to determine whether systemic oxygen therapy delivered through face mask would have beneficial effects on the healing of corneal epithelial wound in post-vitrectomy diabetic patients. It will be a prospective, randomised interventional clinical study conducted on diabetic patients indicated for vitrectomy. Rationale of this study is to see if systemic oxygen delivered via face mask will hasten the resolution of corneal epithelial defects, which may either be iatrogenic (surgically-induced intra-operatively to enable clearer visualisation for the surgeon) or spontaneous (due to corneal epithelial fragility which is commoner in diabetics)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic patients aged 18 years and above planned for pars plana vitrectomy that required intra-operative corneal epithelial debridement to allow better surgical visualisation of the fundus were recruited within the study duration\n\nExclusion Criteria:\n\n* pre-existing ocular surface or corneal disease, recent eye surgery within one month from the vitrectomy, glaucoma and if the patients have any contraindications to oxygen therapy (e.g. chronic obstructive pulmonary disease).'}, 'identificationModule': {'nctId': 'NCT02344732', 'briefTitle': 'Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy', 'orgStudyIdInfo': {'id': 'NMRR-13-449-15617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Group', 'description': 'topical Maxitrol™ six-hourly and homatropine 2% six-hourly', 'interventionNames': ['Drug: Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily', 'Drug: Homatropine 2% eye drops thrice daily']}, {'type': 'EXPERIMENTAL', 'label': 'Oxygen Group', 'description': 'standard medical treatment of topical Maxitrol™ six-hourly and homatropine 2% six-hourly, plus systemic oxygen via simple face mask at 10 litres/min for one hour, in 12-hourly sessions for 3 days', 'interventionNames': ['Drug: Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily', 'Drug: Homatropine 2% eye drops thrice daily', 'Drug: Oxygen gas']}], 'interventions': [{'name': 'Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily', 'type': 'DRUG', 'otherNames': ['Maxitrol'], 'armGroupLabels': ['Oxygen Group', 'Standard Group']}, {'name': 'Homatropine 2% eye drops thrice daily', 'type': 'DRUG', 'armGroupLabels': ['Oxygen Group', 'Standard Group']}, {'name': 'Oxygen gas', 'type': 'DRUG', 'armGroupLabels': ['Oxygen Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wee-Min Teh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Teh Wee Min', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}