Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT00658502
Status:
UNKNOWN
Last Update Posted:
2008-04-15
First Post:
2008-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D015858', 'term': 'Anisometropia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-14', 'studyFirstSubmitDate': '2008-04-11', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2008-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'axial length, corneal hysteresis', 'timeFrame': '3 month'}], 'secondaryOutcomes': [{'measure': 'Refractive error, visual acuity, , intraocular pressure, , and corneal thickness', 'timeFrame': '3 month'}]}, 'conditionsModule': {'conditions': ['Myopia', 'Anisometropia']}, 'descriptionModule': {'briefSummary': 'Our study has three parts has three parts, and the main aim of the study is to find out if corneal hysteresis was associated with myopia or even a predictor of myopia poor control predictor:\n\n* Part 1 of our study: patients with anisomeropia whose spherical equivalent refraction as measured by cycloplegic autorefraction between the two eyes differ greater than 1.5 D.\n* Part 2 of our study: Minus spherical equivalent refraction as measured by cycloplegic autorefraction.\n* Part 3 of our study: patients with minus spherical equivalent refraction as measured by cycloplegic autorefraction who are under regular atropine for the treatment of myopia;patients who are prescribed with atropine treatment are in need of myopia control instead of for research interest'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'age under 25 year old with or without myopia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Normal ocular health other than myopia or anisometropia\n2. In good general health with no history of prematurity or cardiac or significant respiratory diseases\n3. No allergy to atropine, tropicamide, proparacaine, and benzalkonium chloride\n4. No previous or current use of contact lenses, bifocals, progressive addition lenses\n5. No amblyopia or manifest strabismus, including intermittent tropia\n\nExclusion Criteria:\n\n1. presence of keratoconus or other corneal disease\n2. previous eye drops usage except Atropine\n3. major ocular surgery history (including refractive surgery, scleral buckle, glaucoma filtering, cornea transplant, cataract and vitreoretinal surgery)\n4. presence of other ocular conditions such as glaucoma, uveitis, or other ocular inflammatory or vitreoretinal diseases.'}, 'identificationModule': {'nctId': 'NCT00658502', 'briefTitle': 'Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment', 'orgStudyIdInfo': {'id': 'FEMH97006'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}, {'label': '2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'Banqiao District', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shu-Wen Chang, MD', 'role': 'CONTACT', 'email': 'swchang@ntu.edu.tw', 'phone': '886-8966-2000', 'phoneExt': '2601'}, {'name': 'Shu-Wen Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}], 'centralContacts': [{'name': 'Shu-Wen Chang, MD', 'role': 'CONTACT', 'email': 'swchang@ntu.edu.tw', 'phone': '886-8966-7000', 'phoneExt': '2601'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shu-Wen Chang/Far Eastern Memorial Hospital', 'oldOrganization': 'Far Eastern Memorial Hospital'}}}}