Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:40 AM
Study NCT ID:
NCT07307820
Status:
COMPLETED
Last Update Posted:
2025-12-29
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sutureless Glueless Technique Versus Interrupted Suturing for Conjunctival Autograft Fixation After Primary Pterygium Excision: Anterior Segment Optical Coherence Tomography (ASOCT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized contralateral-eye design, where each patient contributed both eyes, one receiving sutured and the other sutureless graft fixation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft stability: incidence of slippage or recession (%) - Secondary (Safety/Complication)', 'timeFrame': 'Time Frame: Within 1 month postoperatively', 'description': 'Proportion of eyes with clinically significant graft slippage or marginal recession requiring intervention or observed during follow-up.'}, {'measure': 'Patient-reported discomfort (VAS 0-10) - Secondary', 'timeFrame': 'Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4', 'description': 'Mean Visual Analogue Scale (0 = no discomfort to 10 = worst possible) recorded at each visit.'}, {'measure': 'Cosmetic outcome - surgeon-rated score (0-10)', 'timeFrame': 'Time Frame: 4 weeks (Month 1) postoperatively', 'description': "Surgeon's cosmetic grading based on redness, graft contour and surface smoothness (0 = poor to 10 = excellent)."}], 'secondaryOutcomes': [{'measure': 'Interface reflectivity (qualitative grading: low/moderate/high)', 'timeFrame': 'Time Frame: Week 1, Week 2, Week 3, Week 4', 'description': 'Qualitative grading of graft-host interface reflectivity on AS-OCT to indicate edema/fibrosis; images assessed by masked grader(s).'}, {'measure': 'Change in central graft thickness (µm) -', 'timeFrame': 'Baseline (Day 1) to Week 4', 'description': 'Absolute and percent change in central graft thickness from Day 1 to Week 4 measured by AS-OCT.'}, {'measure': 'Mean central graft thickness measured by AS-OCT (µm)', 'timeFrame': 'Time Frame: 4 weeks (Month 1) postoperatively', 'description': 'Description: Mean central conjunctival autograft thickness measured by anterior-segment OCT at 4 weeks after surgery. Measurement performed using device calipers on the central graft area; reported as mean ± SD per group. This endpoint assesses final early structural integration and resolution of postoperative edema.'}, {'measure': 'Conjunctival congestion score (0-3)', 'timeFrame': 'Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4', 'description': 'Clinician-graded vascular hyperemia (0 = none; 1 = mild; 2 = moderate; 3 = severe) at each visit.'}, {'measure': 'Gutter size at graft-host junction (µm)', 'timeFrame': 'Time Frame: Week 1, Week 2, Week 3, Week 4', 'description': 'Linear measurement of the graft-host interface gap (gutter) by AS-OCT at each follow-up; reported as mean ± SD.'}, {'measure': 'Operative time (minutes) - Secondary', 'timeFrame': 'Time Frame: At surgery (intraoperative)', 'description': 'Duration from incision to completion of graft fixation, recorded in minutes for each eye.'}, {'measure': 'Early recurrence (clinical evidence of fibrovascular regrowth at limbus) -', 'timeFrame': 'Time Frame: 4 weeks (Month 1) postoperatively', 'description': 'Presence or absence of early fibrovascular regrowth onto cornea at 1 month (noting that longer follow-up is required for definitive recurrence rates).'}, {'measure': 'Adverse events (type and severity) - Secondary (Safety)', 'timeFrame': 'Time Frame: Within 1 month postoperatively', 'description': 'All adverse events related to the procedure recorded and graded (e.g., infection, granuloma, graft loss), with details on management'}, {'measure': 'Donor site epithelialization (complete: Y/N and time to healing in days) - Secondary', 'timeFrame': 'Time Frame: Assessed weekly up to 4 weeks', 'description': 'Presence of complete re-epithelialization of donor site confirmed clinically and by AS-OCT; record time (days) to complete healing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary pterygium, ASOCT, conjunctival autograft surgery'], 'conditions': ['Primary Pterygium, ASOCT, Conjunctival Autograft Surgery']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Natung T, et al. Sutureless, glue-less conjunctival autograft versus sutured autograft in primary pterygium surgery. PMC article. 2017'}, {'type': 'BACKGROUND', 'citation': 'Mahajan S, et al. A Comparative Study of Suture-less and Glue-Free versus Sutured Conjunctival Autograft in Pterygium Surgery. Arch of Medical & Health Science. 2021'}, {'pmid': '39200911', 'type': 'BACKGROUND', 'citation': 'Aguilar-Gonzalez M, Espana-Gregori E, Pascual-Camps I, Gomez-Lechon-Quiros L, Peris-Martinez C. Prospective Study: Utility of Anterior Segment Optical Coherence Tomography to Identify Predictive Factors of Recurrence in Pterygium Surgery. J Clin Med. 2024 Aug 14;13(16):4769. doi: 10.3390/jcm13164769.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the clinical and Anterior segment optical coherence tomography (ASOCT) outcomes between sutured and sutureless conjunctival autograft fixation techniques in the management of primary pterygium.\n\nA total of 30 patients with bilateral primary pterygia were included. Each patient underwent pterygium excision in both eyes: one eye received graft fixation using interrupted 10-0 nylon sutures, while the fellow eye received sutureless fixation. Allocation of technique between eyes was randomized.\n\nAll surgeries were performed by the same surgeon, and patients were followed up weekly for one month. Parameters assessed included graft thickness, interface reflectivity, gutter size, conjunctival congestion, donor site healing, and postoperative discomfort using a visual analogue scale.\n\nThe study evaluates which fixation method provides faster healing, better cosmetic results, and fewer complications such as graft slippage or recession, especially in relation to pterygium size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria Age 18 to 65 years (both sexes). Diagnosis of bilateral primary nasal pterygium requiring surgical excision (both eyes affected).\n\nHorizontal corneal encroachment of the pterygium ≥ 2.0 mm in each eye. Lesions amenable to conjunctival autograft coverage with expected graft size obtainable from superior bulbar conjunctiva.\n\nWillingness and ability to attend scheduled follow-up visits for 1 month postoperatively.\n\nAble to provide written informed consent.\n\nExclusion Criteria Recurrent pterygium in either eye. Previous ocular surgery on the study eye(s) (including prior pterygium surgery) or conjunctival grafting.\n\nActive ocular surface disease or infection (e.g., conjunctivitis, keratitis) at screening.\n\nSevere dry eye disease (e.g., Schirmer's test ≤ 5 mm or TBUT \\< 5 s) likely to affect healing.\n\nSignificant ocular comorbidities affecting wound healing or outcome interpretation: uncontrolled glaucoma with conjunctival filtering surgery, ocular surface cicatrizing disorders (e.g., ocular pemphigoid), severe blepharitis, or severe meibomian gland dysfunction.\n\nSystemic conditions that impair wound healing or increase surgical risk (e.g., uncontrolled diabetes mellitus with HbA1c \\> 8.0%, connective tissue disorders, immunosuppression, chronic systemic corticosteroid use).\n\nCurrent use of anticoagulant therapy that cannot be safely paused per local perioperative protocol (if this precludes safe graft fixation).\n\nPregnancy or breastfeeding. Known allergy to any material used in the procedure or postoperative medications.\n\nInability to comply with follow-up schedule or provide informed consent (e.g., cognitive impairment, planning to move away)."}, 'identificationModule': {'nctId': 'NCT07307820', 'acronym': 'ASOCT', 'briefTitle': 'Sutureless Glueless Technique Versus Interrupted Suturing for Conjunctival Autograft Fixation After Primary Pterygium Excision: Anterior Segment Optical Coherence Tomography (ASOCT) Study', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Sutureless Glueless Technique Versus Interrupted Suturing for Conjunctival Autograft Fixation After Primary Pterygium Excision: Anterior Segment Optical Coherence Tomography (ASOCT) Study', 'orgStudyIdInfo': {'id': '166072025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sutured conjunctival autograft fixation', 'description': 'conjunctival autograft secured with interrupted 10/0 nylon after pterygium exision', 'interventionNames': ['Procedure: sutured conjunctival autograft fixation']}, {'type': 'EXPERIMENTAL', 'label': 'sutureless glueless conjunctival autograftfixation', 'description': 'Conjunctival autograft placed without sutures, relying on natural adhesion and fibrin clot formation.', 'interventionNames': ['Procedure: Sutureless Conjunctival Autograft Fixation']}], 'interventions': [{'name': 'sutured conjunctival autograft fixation', 'type': 'PROCEDURE', 'description': 'After pterygium excision, a conjunctival autograft is secured in place using interrupted 10-0 nylon sutures to ensure graft stability and promote healing', 'armGroupLabels': ['sutured conjunctival autograft fixation']}, {'name': 'Sutureless Conjunctival Autograft Fixation', 'type': 'PROCEDURE', 'description': 'Following pterygium excision, the conjunctival autograft is placed without sutures, relying on natural adhesion and fibrin clot formation to maintain graft position.', 'armGroupLabels': ['sutureless glueless conjunctival autograftfixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'state': 'Minia Governorate', 'country': 'Egypt', 'facility': 'Minia University Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to institutional policies regarding patient privacy and confidentiality, as well as restrictions based on ethical committee requirements. Data sharing may be reconsidered upon formal request and in compliance with all relevant regulations protecting participant information."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of ophthalmolgy', 'investigatorFullName': 'Mahmoud Ramadan', 'investigatorAffiliation': 'Minia University'}}}}