Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-30 @ 6:14 AM
Study NCT ID:
NCT06543212
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2024-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Alignment and Eye Control Changes Through Follow up Period After Application of Eye Exercises Post Strabismus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2024-08-04', 'studyFirstSubmitQcDate': '2024-08-04', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye deviation by prism-cover test', 'timeFrame': '3 months', 'description': 'This test is used to quantify the movement of deviating eye'}, {'measure': 'Measurement of eye control by Intermittent Exotropia Control Scale', 'timeFrame': '3 months', 'description': 'The level of control will be evaluated in each patient at both distance and near fixation using Intermittent Exotropia Control Scale. The scale ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Strabismus; Intermittent']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the patient status through its follow up period and weather the eye alignment and eye control are as the same as the last physiotherapy treatment session or there is any deterioration of them.', 'detailedDescription': 'This study is quantitative cohort observational study. The study depends on following a group of participants over a period of time ( 2 months after completed physiotherapy training program for 3 months to improve eye alignment and eye control post strabismus surgery ).\n\nThrough the study, there is observation to the changes in certain quantitative variables ( eye alignment and eye control ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population from both groups will be selected from Research Institute of Ophthalmology and completed physiotherapy training program for 3 months to improve eye alignment and eye control post strabismus surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients are both males and females.\n* Their age will range from (5-15) years.\n* All Patients received physiotherapy training for improving eye alignment and eye control.\n* Patients applied the physiotherapy rehabilitation program for 3 months with the physiotherapist.\n* All Patients complete their physiotherapy training sessions for improving eye alignment and eye control\n* All Patients have a history of strabismus surgery.\n* Intermittent exotropia was the type of strabismus which included to the study.\n\nExclusion Criteria:\n\n* \\- Patient who didn't receive physiotherapy training program for improving eye control and eye alignment post strabismus surgery.\n* Patient who didn't complete the physiotherapy training program for 3 months.\n* Muscular disorders that will impair performance during training.\n* Any organic lesion in the eye.\n* Neurological disorders.\n* Malignant conditions.\n* Psychiatric illness, severe behavior or cognitive disorders."}, 'identificationModule': {'nctId': 'NCT06543212', 'briefTitle': 'Eye Alignment and Eye Control Changes Through Follow up Period After Application of Eye Exercises Post Strabismus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Eye Alignment and Eye Control Changes Through Follow up Period After Application of Eye Exercises Post Strabismus Surgery', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004678'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group continues with physiotherapy', 'description': 'Group continues with physiotherapy training in follow up period after last session of physiotherapy program post strabismus surgery.', 'interventionNames': ['Other: physiotherapy exercises']}, {'label': "group doesn't continue with physiotherapy", 'description': "Group doesn't continue with physiotherapy training in follow up period after last session of physiotherapy program post strabismus surgery"}], 'interventions': [{'name': 'physiotherapy exercises', 'type': 'OTHER', 'description': 'physiotherapy exercises to improve eye alignment and eye control post strabismus surgery', 'armGroupLabels': ['group continues with physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Amany Abdel Wahid, Post doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer at faculty of physical therapy, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amany Refaat Mohamed Abdel Wahid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer at faculty of physical therapy, Cairo University', 'investigatorFullName': 'Amany Refaat Mohamed Abdel Wahid', 'investigatorAffiliation': 'Cairo University'}}}}