Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT07143032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005099', 'term': 'Exotropia'}], 'ancestors': [{'id': 'D013285', 'term': 'Strabismus'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in ocular alignment', 'timeFrame': 'at one month, 6 month and one year postoperatively.', 'description': 'Detect ocular alignment by using Krimsky test to measure angle of deviation in prism diopter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exotropia', 'Recession', 'Resection', 'Transplantation'], 'conditions': ['Exotropia Equal or More Than 50 Prism Diopter']}, 'referencesModule': {'references': [{'pmid': '29199031', 'type': 'BACKGROUND', 'citation': 'Cifuentes DL, Pineles SL, Demer JL, Velez FG. Surgical success and lateral incomitance following three-muscle surgery for large-angle horizontal strabismus. J AAPOS. 2018 Feb;22(1):17-21. doi: 10.1016/j.jaapos.2017.10.005. Epub 2017 Dec 1.'}, {'pmid': '32510018', 'type': 'BACKGROUND', 'citation': 'Talebnejad MR, Johari MK, Khalili MR, Zare M. Supramaximal Recession and Resection Surgery in Large-Angle Strabismus: Outcomes of Large Interventional Case Series Exotropia and Esotropia. J Curr Ophthalmol. 2020 Mar 23;32(1):82-87. doi: 10.4103/JOCO.JOCO_22_20. eCollection 2020 Jan-Mar.'}, {'pmid': '21149163', 'type': 'BACKGROUND', 'citation': 'Peters ER, Archer SM. Long-standing, large-angle exotropia in adults. Am Orthopt J. 2007;57:104-6. doi: 10.3368/aoj.57.1.104.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized comparative interventional study that aims to compare the surgical outcomes of correcting large angle exotropia (≥50 prism diopter) by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation,', 'detailedDescription': 'This is a randomized comparative interventional study that will be conducted on patients with large angle exotropia before and after doing surgical correction using three different surgical techniques including : 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with large-angle exotropia (≥50 prism diopter).\n\nExclusion Criteria:\n\n1. Patients with an exodeviation angle of less than 50 prism diopter.\n2. History of previous strabismus surgery.\n3. Restrictive or paretic strabismus or history of botulinum toxin injections for strabismus.'}, 'identificationModule': {'nctId': 'NCT07143032', 'briefTitle': 'A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia: Bilateral Lateral Rectus Recession With Medial Rectus Resection, Bilateral Medial Rectus Resection and Resection-Transplantation', 'orgStudyIdInfo': {'id': 'Soh-Med-25-7-4MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection', 'description': 'patients with large angle exotropia treated by bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection', 'interventionNames': ['Procedure: Extropia squint surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bilateral medial rectus muscle resection', 'description': 'patients with large angle exotropia treated by bilateral medial rectus muscle resection', 'interventionNames': ['Procedure: Extropia squint surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'unilateral medial rectus muscle resection with lateral rectus muscle transplantation', 'description': 'patients with large angle exotropia treated by unilateral medial rectus muscle resection with lateral rectus muscle transplantation', 'interventionNames': ['Procedure: Extropia squint surgery']}], 'interventions': [{'name': 'Extropia squint surgery', 'type': 'PROCEDURE', 'description': 'patients with large angle exotropia will be treated by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them.', 'armGroupLabels': ['bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection', 'bilateral medial rectus muscle resection', 'unilateral medial rectus muscle resection with lateral rectus muscle transplantation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'sara ahmed abdelraheem, Assistant lecturer', 'role': 'CONTACT', 'email': 'sara011096@med.sohag.edu.eg', 'phone': '+201153987387'}, {'name': 'Alahmady Hamad Alsaman, Professor', 'role': 'CONTACT', 'phone': '+201111102698'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Sara Ahmed Abdelraheem', 'investigatorAffiliation': 'Sohag University'}}}}