Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT03952702
Status:
UNKNOWN
Last Update Posted:
2019-05-16
First Post:
2019-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Overminus Lens Therapy in Intermittent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.', 'timeFrame': '4 years', 'description': 'Overminus lenses were prescribed on the treatment of intermittent exotropia as the first choice. To investigate the effect of overminus lenses on treatment, progress in fusional capability of the patients evaluated with Newcastle control score system were investigated.'}, {'measure': 'The long-term effect of overminus lenses on stereopsis of patients with intermittent exotropia.', 'timeFrame': '4 years', 'description': 'Changes in stereopsis values (arcsec) evaluated with TNO test were observed.'}, {'measure': 'The long-term effect of prescribing overminus lenses on refractive changes.', 'timeFrame': '4 years', 'description': 'Refractive data of the patients in terms of dioptri were measured with autorefractometer during the long-term follow-up period to observe presence of any myopic shift.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intermittent exotropia', 'overminus lens therapy', 'myopic overcorrection'], 'conditions': ['Intermittent Exotropia', 'Myopia Overcorrection', 'Over-minus Therapy', 'Myopia Progression']}, 'descriptionModule': {'briefSummary': 'In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.', 'detailedDescription': 'Purpose: To evaluate the long-term impact of overminus lenses in intermittent exotropia (IXT), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia.\n\nMaterials and Method: Sixty-five consecutive cases of IXT followed for at least 48 months were included. Patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (\\>-5.0 D), severe hyperopia (\\>+5.0 D), moderate or severe amblyopia and poor compliance with spectacles were excluded. Data was collected including near stereoacuity, AC/A ratio, control of IXT measured with Newcastle Control Score (NCS) at baseline and in all follow-up visits. Baseline values without overminus threapy were compared with postintervention values at every visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with IXT\n* prescribed overminus lenses\n\nExclusion Criteria:\n\n* a history of previous surgery, ocular pathology\n* convergence insufficiency type IXT\n* presence of any type of ocular deviation except IXT\n* presence of severe myopia (greater than -5.0 D)\n* presence of severe hyperopia (greater than +5.0 D)\n* presence of moderate or severe amblyopia\n* poor compliance with overminus spectacles\n* follow up period of \\<48 months after intervention.'}, 'identificationModule': {'nctId': 'NCT03952702', 'briefTitle': 'Overminus Lens Therapy in Intermittent', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia', 'orgStudyIdInfo': {'id': 'Ege30042919'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Myopic overcorrection', 'type': 'PROCEDURE', 'description': 'Myopic overcorrection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35040', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Faculty of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof., M.D.', 'investigatorFullName': 'Elif Demirkilinc Biler', 'investigatorAffiliation': 'Ege University'}}}}