Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-02 @ 8:08 AM
Study NCT ID:
NCT01480934
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2011-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2011-11-24', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Posterior capsule opacification.', 'timeFrame': '4 years', 'description': "This prospective, observational case control study comprised patients who underwent phacoemulsification .Subjects with a history of diabetes mellitus (DM) were designated as cases (n=75 eyes).Inclusion criteria for cases: Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more , use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes. Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls (n=75 eyes)."}], 'secondaryOutcomes': [{'measure': 'duration of diabetes, stage of diabetic retinopathy', 'timeFrame': '4 years', 'description': 'The stage of diabetic retinopathy and duration of diabetes was correlated with the degree of PCO in the cases group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes,posterior capsule opacification,case control study'], 'conditions': ['Development of Posterior Capsule Opacification']}, 'descriptionModule': {'briefSummary': 'To compare the development of posterior capsule opacification (PCO) between eyes with and without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not increase the incidence of PCO at 4 years.', 'detailedDescription': 'There is a paucity of available literature that prospectively evaluates the development of PCO with the single-piece hydrophobic acrylic IOL implantation in diabetic versus non-diabetic eyes on a long-term basis. Therefore, this study was designed to compare the degree of PCO after cataract surgery between diabetic and age-matched non-diabetic patients. This prospective, observational case control study comprised patients who underwent phacoemulsification .The patients were asked to return for postoperative follow-up visits at 1 month, 1 year and 4 years.\n\nthe digital images were analyzed for PCO .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent phacoemulsification for age-related cataract', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more ,\n* use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes.\n* Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls (n=75 eyes).\n\nExclusion Criteria:\n\n* patients with glaucoma,\n* high myopia (axial length \\> 27.0 mm),\n* pseudoexfoliation,\n* traumatic cataract,\n* subluxated cataract,\n* previous ocular surgeries,\n* allergy to dilating drops."}, 'identificationModule': {'nctId': 'NCT01480934', 'acronym': 'DM & PCO', 'briefTitle': 'Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Iladevi Cataract and IOL Research Center'}, 'officialTitle': 'A Prospective Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus -A Case Control Study', 'orgStudyIdInfo': {'id': '01072007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group:A-cases-Patients with a history of Diabetes Mellitus', 'description': "(N=75 eyes). The inclusion criteria for group A: Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more , use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes."}, {'label': 'Group - B:controls', 'description': 'Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls(Group:)B (n=75 eyes).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gauri D Shah, M.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iladevi Cataract &IOL Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iladevi Cataract and IOL Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}