Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 5:01 PM
Study NCT ID:
NCT04322656
Status:
UNKNOWN
Last Update Posted:
2022-10-17
First Post:
2020-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stability of Biometry in 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spherical and toric IOL power selected at baseline and at 3 months visit', 'timeFrame': '12 months', 'description': 'The difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lipiflow', 'Meibomian gland dysfunction', 'Biometry'], 'conditions': ['Meibomian Gland Dysfunction']}, 'descriptionModule': {'briefSummary': "Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. However, some recent studies indicate that preoperative biometry is influenced by dry eye disease (DED). Hence, the investigator's study aims to investigate the effect of the therapy of MGD using the Lipiflow® device on the stability of biometry and selection of IOL.", 'detailedDescription': 'Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. 31 Patients suffering from DED caused by MGD will be selected and allocated randomly to therapy. Patients with pre-existing DED therapy other than lubricants will be excluded. After completing prestudy-screening and baseline visit, Lipiflow® therapy is applied to the study eye. Follow-up visits will be scheduled two weeks and three months after baseline visit. Each visit includes dry eye investigations and IOL calculation by IOLmaster 700 and CSO MS-39. After each study visit an IOL will be theoretically selected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18 years\n* Evidence of meibomian gland dysfunction\n* Meibomian gland secretion score equal or less than 15 (for 15 glands of the lower eye lid) using the meibomian gland evaluator (see below)\n\nExclusion Criteria:\n\n* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)\n* Usage of systemic antibiotic therapy\n* Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)\n* Ocular surgery within prior 3 months\n* Ocular injury within prior 3 months\n* Ocular herpes of eye or eyelid within prior 3 months\n* Active ocular infection\n* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months\n* Eyelid abnormalities that affect lid function\n* Ocular surface abnormality that may compromise corneal integrity\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04322656', 'briefTitle': 'Stability of Biometry in Meibomian Gland Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Stability of Biometry in Patients With Meibomian Gland Dysfunction', 'orgStudyIdInfo': {'id': 'LPF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Effect of Lipiflow treatment on biometrical outcomes', 'description': 'One eye of each patient will be treated with Lipiflow', 'interventionNames': ['Device: Lipiflow treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Control eye', 'description': 'The contralateral eye will serve as control eye'}], 'interventions': [{'name': 'Lipiflow treatment', 'type': 'DEVICE', 'description': 'Patients will be treated on one eye with Lipiflow', 'armGroupLabels': ['Effect of Lipiflow treatment on biometrical outcomes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Oliver Findl, Univ.Prof. Dr.', 'role': 'CONTACT', 'email': 'oliver@findl.at', 'phone': '+43 1 91021-84611'}, {'name': 'Stefan Palkovits, Priv.Doz. Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oliver Findl, Univ.Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vienna Institute for Research in Ocular Surgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Oliver Findl, Univ.Prof. Dr.', 'role': 'CONTACT', 'email': 'oliver@findl.at', 'phone': '+43 1 91021-84611'}, {'name': 'Stefan Palkovits, Priv.Doz. Dr.', 'role': 'CONTACT', 'email': 'spalkovits@viros.at', 'phone': '+43 1 91021-84611'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}