Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 12:01 PM
Study NCT ID:
NCT03204903
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2017-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Acupuncture for Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sham laser acupuncture: laser acupuncture without laser output.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2017-05-21', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index', 'timeFrame': '12 weeks', 'description': 'The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision.'}], 'secondaryOutcomes': [{'measure': 'Schirmer test', 'timeFrame': '12 weeks', 'description': "A Schirmer's test is used to assess how quickly the eyes produce tears."}, {'measure': 'Visual analogue scale of eye discomfort', 'timeFrame': '12 weeks', 'description': 'A 10-cm visual analog scale (0-10 points, least to greatest discomfort intensity, VAS) was used to measure the intensity of eye discomfort.'}, {'measure': 'Tear film break-up time', 'timeFrame': '12 weeks', 'description': 'Tear film break-up time (TFBUT) measures the time required for tears to naturally evaporate and diffuse after blinking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry eye', 'Laser acupuncture', 'Traditional Chinese medicine'], 'conditions': ['Dry Eye']}, 'referencesModule': {'references': [{'pmid': '21070615', 'type': 'BACKGROUND', 'citation': 'Shin MS, Kim JI, Lee MS, Kim KH, Choi JY, Kang KW, Jung SY, Kim AR, Kim TH. Acupuncture for treating dry eye: a randomized placebo-controlled trial. Acta Ophthalmol. 2010 Dec;88(8):e328-33. doi: 10.1111/j.1755-3768.2010.02027.x. Epub 2010 Nov 10.'}, {'pmid': '33904792', 'type': 'DERIVED', 'citation': 'Hu WL, Yu HJ, Pan LY, Wu PC, Pan CC, Kuo CE, Tseng YJ, Hung YC. Laser Acupuncture Improves Tear Film Stability in Patients with Dry Eye Disease: A Two-Center Randomized-Controlled Trial. J Altern Complement Med. 2021 Jul;27(7):579-587. doi: 10.1089/acm.2020.0524. Epub 2021 Apr 27.'}, {'pmid': '29851803', 'type': 'DERIVED', 'citation': 'Hu WL, Wu PC, Pan LY, Yu HJ, Pan CC, Hung YC. Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.'}]}, 'descriptionModule': {'briefSummary': 'Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.', 'detailedDescription': 'Objective: Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye.\n\nMethods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 20 \\< age \\< 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent.\n* Tear film break-up time \\< 10 s\n* Schirmer's strips with anesthesia \\< 5mm/ 5min\n\nExclusion Criteria:\n\n* presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens\n* pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis\n* critical illness such as Stevens-Johnson syndrome, etc\n* has taken or needs active treatment (including Chinese medicine)\n* presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin\n* does not meet the physician's assessment for recruitment\n* lack of informed consent."}, 'identificationModule': {'nctId': 'NCT03204903', 'briefTitle': 'Laser Acupuncture for Dry Eye', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Laser Acupuncture Therapy in Patients With Dry Eye: A Two-center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CMRPG8F0551'}, 'secondaryIdInfos': [{'id': '201600333A3', 'type': 'OTHER', 'domain': 'Chang Gung Medical Foundation Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser acupuncture', 'description': 'The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using laser acupuncture during 3 sessions per week for 12 weeks.', 'interventionNames': ['Procedure: Laser acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham laser acupuncture', 'description': 'The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using sham laser acupuncture (without laser output) during 3 sessions per week for 12 weeks.', 'interventionNames': ['Procedure: Sham laser acupuncture']}], 'interventions': [{'name': 'Laser acupuncture', 'type': 'PROCEDURE', 'description': 'Subjects were treated 3 times per week for 12 weeks with the LaserPen (GaAlAs laser diode, 810 nm, 150 mW, pulsed waves), which delivered 0.375 J of energy (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.', 'armGroupLabels': ['Laser acupuncture']}, {'name': 'Sham laser acupuncture', 'type': 'PROCEDURE', 'description': 'Subjects were treated 3 times per week for 12 weeks with the LaserPen without laser output (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.', 'armGroupLabels': ['Sham laser acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wen-Long Hu, MD, MS', 'role': 'CONTACT', 'email': 'oolonghu@gmail.com', 'phone': '+886-7-7317123', 'phoneExt': '6255'}], 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Wen-Long Hu, MD, MS', 'role': 'CONTACT', 'email': 'oolonghu@gmail.com', 'phone': '+886-7-7317123', 'phoneExt': '6255'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}