Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT01709916
Status:
COMPLETED
Last Update Posted:
2015-02-24
First Post:
2012-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-23', 'studyFirstSubmitDate': '2012-10-17', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP at different times of the day at same day versus different times and different days', 'timeFrame': '5 weeks', 'description': 'measurements of intra ocular pressure at different times of the day at same day versus different times and different days.'}]}, 'conditionsModule': {'keywords': ['Glaucoma', 'intra ocular pressure', 'diurnal fluctuations'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Glaucoma is one of the leading causes of blindness in the west. The disease caused by high intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of the therapy it is common to measure the intra ocular pressure at different times of the day. Most ophthalmologists admit the patient for one day at which intra ocular pressure is measured at different times. This method does not mimic the patient daily routine and may not reflect the true diurnal fluctuations.\n\nFor this reason some ophthalmologists measure the intra ocular pressure at different times and at different days. It is not known if both methods give similar diurnal curves.', 'detailedDescription': 'A study physician will install anesthetic eye drops and will color the eye drops film with fluorescein. Study physician will use tonometer to measure the intra ocular pressure in each eye. This is a standard procedure done in any ophthalmological examination. Each patient will undergo intraocular pressure examination at 8:00, 12:00 and 16:00.\n\nIn the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00. One month later the patient will undergo another serious of intra ocular pressure measurements.\n\nIn the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00.\n\nThe relationship between the two diurnal curves will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Glaucoma patients using eye drops to lower intra ocular pressure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glaucoma patient.\n* Age 18-80 years\n* Able to read and understand Hebrew, able to sign informed consent in Hebrew.\n\nExclusion Criteria:\n\n* Ophthalmic laser treatment or surgery 3 months prior to enrollment.\n* Eye infection or inflammation.\n* Corneal pathology altering IOP measurement.\n* Patients not cooperating during IOP measurement.\n* non compliant patients'}, 'identificationModule': {'nctId': 'NCT01709916', 'acronym': 'IOP', 'briefTitle': 'Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients', 'orgStudyIdInfo': {'id': 'CMC-11-0037-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma patients', 'description': 'Glaucoma patients treated with eye drops to lower the IOP.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Orna Geyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Orna Geyer', 'investigatorAffiliation': 'Carmel Medical Center'}}}}