Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-28 @ 5:29 AM
Study NCT ID:
NCT02539758
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2015-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ocular Massage on the Management of Elevated Intraocular Pressure After Acute Angle Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2015-08-08', 'studyFirstSubmitQcDate': '2015-08-31', 'lastUpdatePostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'observed changes of anterior chamber depth before and after ocular massage', 'timeFrame': 'before ocular massage and 15 minutes after massage'}], 'secondaryOutcomes': [{'measure': 'observed changes of intraocular pressure before and after ocular massage', 'timeFrame': 'before ocular massage and 15 minutes after massage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute angle closure', 'ocular massage'], 'conditions': ['Intraocular Pressure']}, 'descriptionModule': {'briefSummary': 'Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma. The effect of ocular massage on intraocular pressure in patients with acute primary angle closure was the important thing.This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy after massage, and anterior chamber angle was also checked by gonioscope after massage.', 'detailedDescription': 'Background: Primary angle closure glaucoma is still the most common type in Asia. Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma, since it has been shown to be effective in reducing optic nerve damage and loss of vision. The objective of this study was to evaluate to assess the effect of ocular massage on intraocular pressure in patients with acute primary angle closure.\n\nMethods : This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry (Lenstar LS900) observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy (after massage, and anterior chamber angle was also checked by gonioscope after massage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All of them had documented evidence of acute angle closure.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02539758', 'briefTitle': 'The Effect of Ocular Massage on the Management of Elevated Intraocular Pressure After Acute Angle Closure', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Eye Hospital'}, 'officialTitle': 'The Effect of Ocular Massage on the Management of Elevated Intraocular Pressure After Acute Angle Closure', 'orgStudyIdInfo': {'id': 'tjykdxykyy2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ocular massage', 'description': 'over the closed eyelids with moderate massage strength for 15 minutes. The compression of the globe was given with finger, and press for 2 seconds, then by a 2 seconds release, with a frequency of 15 presses/minute.We observed changes of anterior chamber depth before and after ocular massage by LenstarLS900,and changes of intraocular pressure before and after ocular massage by Goldmann tonometer', 'interventionNames': ['Other: ocular massage', 'Device: LenstarLS900', 'Device: Goldmann tonometer']}], 'interventions': [{'name': 'ocular massage', 'type': 'OTHER', 'description': 'ocular massage could be applied over the globe over the closed eyelids with moderate massage strength for 15 minutes. The compression of the globe was given with finger, and press for 2 seconds, then by a 2 seconds release, with a frequency of 15 presses/minute.', 'armGroupLabels': ['ocular massage']}, {'name': 'LenstarLS900', 'type': 'DEVICE', 'description': 'observed changes of anterior chamber depth before and after ocular massage by LenstarLS900', 'armGroupLabels': ['ocular massage']}, {'name': 'Goldmann tonometer', 'type': 'DEVICE', 'description': 'observed changes of intraocular pressure before and after ocular massage by Goldmann tonometer', 'armGroupLabels': ['ocular massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300384', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'yingjuan Lv', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Eye Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lv Yingjuan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'department of ophthamology', 'investigatorFullName': 'Lv Yingjuan', 'investigatorAffiliation': 'Tianjin Medical University Eye Hospital'}}}}