Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT03748732
Status:
UNKNOWN
Last Update Posted:
2018-11-21
First Post:
2018-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008850', 'term': 'Microphthalmos'}], 'ancestors': [{'id': 'D005124', 'term': 'Eye Abnormalities'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-18', 'studyFirstSubmitDate': '2018-11-18', 'studyFirstSubmitQcDate': '2018-11-18', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'resolution of uveal effusion', 'timeFrame': '1 month', 'description': 'disappearence of uveal effusion by OCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uveal effusion'], 'conditions': ['Nanophthalmos']}, 'referencesModule': {'references': [{'pmid': '29862063', 'type': 'RESULT', 'citation': 'Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018.'}, {'pmid': '30877130', 'type': 'DERIVED', 'citation': 'Mansour A, Stewart MW, Shields CL, Hamam R, Abdul Fattah M, Sheheitli H, Mehanna CJ, Yassine S, Chahine H, Keaik M, Maalouf F, Jaroudi M. Extensive circumferential partial-thickness sclerectomy in eyes with extreme nanophthalmos and spontaneous uveal effusion. Br J Ophthalmol. 2019 Dec;103(12):1862-1867. doi: 10.1136/bjophthalmol-2018-313702. Epub 2019 Mar 15.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.\n\nDesign: Prospective interventional case series.\n\nMethods:\n\n* Setting: Institutional.\n* Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.\n* Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.\n* Main Outcome Measure: Resolution or prevention of uveal effusion.', 'detailedDescription': 'Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ΒΌ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: nanophthalmos -\n\nExclusion Criteria: None\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03748732', 'briefTitle': 'Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Rafic Hariri University Hospital'}, 'officialTitle': 'Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes', 'orgStudyIdInfo': {'id': 'RaficHaririUHAMM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sclerectomy', 'type': 'PROCEDURE', 'otherNames': ['maximal scleral excision'], 'description': 'scleral flap'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1136044', 'city': 'Beirut', 'state': 'South Beirut', 'country': 'Lebanon', 'facility': 'Rafic Hariri University Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Ahmad Mansour, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rafic Hariri University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'if part of collaboration, we will share the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rafic Hariri University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmad Mansour, MD, Clinical Professor, AUB', 'investigatorAffiliation': 'Rafic Hariri University Hospital'}}}}