Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02618304
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-27', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction', 'timeFrame': '1 and 2 months after treatment of meibomian gland dysfunction'}, {'measure': 'Changes of ocular aberration after treatment of meibomian gland dysfunction', 'timeFrame': '1 and 2 months after treatment of meibomian gland dysfunction', 'description': 'ocular parameters measured by Ray-tracing wavefront aberrometers (i-Trace, Tracey technologies , Texas ,USA)'}], 'secondaryOutcomes': [{'measure': 'Corneal erosion grade(oxford score)', 'timeFrame': '1 and 2 months after treatment of meibomian gland dysfunction'}, {'measure': 'OSDI(ocular surface disease index)', 'timeFrame': '1 and 2 months after treatment of meibomian gland dysfunction'}, {'measure': 'Meibomian gland abnormality', 'timeFrame': '1 and 2 months after treatment of meibomian gland dysfunction', 'description': 'measured by physiological parameter (score 0,1,2,3,4)'}, {'measure': 'Meibomian quality', 'timeFrame': '1 and 2 months after treatment of meibomian gland dysfunction', 'description': 'measured by physiological parameter (score 0,1,2,3,4)'}, {'measure': 'BUT(tear break-up time)', 'timeFrame': '1 and 2 months after treatment of meibomian gland dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meibomian gland dysfunction', 'Lipiview', 'Tear Lipid Layer'], 'conditions': ['Meibomian Gland Dysfunction']}, 'referencesModule': {'references': [{'pmid': '21450920', 'type': 'BACKGROUND', 'citation': 'Asbell PA, Stapleton FJ, Wickstrom K, Akpek EK, Aragona P, Dana R, Lemp MA, Nichols KK. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2065-85. doi: 10.1167/iovs.10-6997h. Print 2011 Mar. No abstract available.'}, {'pmid': '21450919', 'type': 'BACKGROUND', 'citation': "Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available."}, {'pmid': '21450918', 'type': 'BACKGROUND', 'citation': 'Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.'}, {'pmid': '15106913', 'type': 'BACKGROUND', 'citation': 'McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. doi: 10.1016/s0014-4835(03)00203-3.'}]}, 'descriptionModule': {'briefSummary': 'In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. age over 19 years old, with moderate to severe Meibomian gland dysfunction.\n\nExclusion Criteria:\n\n1. patients with history of previous ocular or intraocular surgery\n2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease\n3. history of intolerance or hypersensitivity to any component of the study medications\n4. wearing contact lenses during the study period, presence of current punctal occlusion\n5. pregnancy, lactating women, and children'}, 'identificationModule': {'nctId': 'NCT02618304', 'briefTitle': 'Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '1-2015-0012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'moderate to severe meibomian gland dysfunction', 'interventionNames': ['Drug: Treatment of Meibomian gland dysfunction']}], 'interventions': [{'name': 'Treatment of Meibomian gland dysfunction', 'type': 'DRUG', 'description': 'artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.', 'armGroupLabels': ['moderate to severe meibomian gland dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Ophthalmology, Yonsei Univeristy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}