Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-02 @ 1:12 PM
Study NCT ID:
NCT05156151
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal transparency', 'timeFrame': '12 months', 'description': 'Implantation of corneal stromal lenticules with stromal stem cells, live keratocytes and telocytes, stromal haze and scar have been successfully treated and stabilized the biomechanical stability of cornea in 87% of the patients which underwent this treatment.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of visual acuity', 'timeFrame': '12 months', 'description': 'Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stromal Keratitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.', 'detailedDescription': 'Stromal keratitis is an infectious ocular disease of either necrotizing or non-necrotizing form, due to an HSV infection, and characterized by corneal stromal necrosis, inflammation, ulceration and infiltration by leukocytes.\n\nIn our study these early findings suggest that the use of corneal stromal lenticules with stromal stem cells and live keratocytes could be a safe and efficient treatment for stromal scar after herpetic keratitis, and excluding the recurrence of the disease by removing the corneal scar after herpetic infection using Smile and implanting the lenticule equal to the volume of the removed scar tissue.\n\nStromal lenticule implantation is relatively simple, low-cost and offers advantages over corneal transplantation as a definitive procedure in the treatment of this disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* low transparenc of cornea\n* low visual acuity\n* recurrence of herpetic stromal keratitis\n\nExclusion Criteria:\n\n* previous corneal or anterior segment surgery\n* any infection'}, 'identificationModule': {'nctId': 'NCT05156151', 'acronym': 'Relex-Smile', 'briefTitle': 'Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis', 'organization': {'class': 'OTHER', 'fullName': 'Eye Hospital Pristina Kosovo'}, 'officialTitle': 'Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis', 'orgStudyIdInfo': {'id': 'EyehospitalPrishtina'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Stromal lenticule implantation for management of herpetic stromal keratitis', 'description': 'The thickness of the herpetic stromal scar in the cornea is calculated in microns in OCT. Based on that extraction is performed using SMILE, a new lenticular stromal pocket is placed in the same volume. AS-OCT evaluated the corneal topography, glass-corrected best visual acuity (BSCVA) measurements and electron microscopy. Postoperative complications were monitored during the follow-up period.\n\nDuring the three year follow-up period, no signs of recurrence or infections were detected in this patient.', 'interventionNames': ['Other: Relex-Smile']}], 'interventions': [{'name': 'Relex-Smile', 'type': 'OTHER', 'armGroupLabels': ['Stromal lenticule implantation for management of herpetic stromal keratitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Pristina', 'country': 'Kosovo', 'facility': 'Eye Hospital Pristina', 'geoPoint': {'lat': 42.67272, 'lon': 21.16688}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye Hospital Pristina Kosovo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Ophthalmology Department', 'investigatorFullName': 'Dr. Faruk Semiz', 'investigatorAffiliation': 'Eye Hospital Pristina Kosovo'}}}}