Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT04793893
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-11-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase of visual acuity', 'timeFrame': '12 months', 'description': 'Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors.\n\nResidual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)', 'detailedDescription': 'The main problem at young patients post - LASIK after one year is residual refractive errors.\n\nThe method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D).\n\n1. The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap.\n2. The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residual hypermetropic refraction,\n* low visual acuity\n\nExclusion Criteria:\n\n* active anterior segment pathology,\n* glaucoma,\n* retinae detachment,'}, 'identificationModule': {'nctId': 'NCT04793893', 'acronym': 'Relex-Smile', 'briefTitle': 'Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Eye Hospital Pristina Kosovo'}, 'officialTitle': 'Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation Using Relex Smile Surgery', 'orgStudyIdInfo': {'id': 'EPristinaHospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment of residual hypermetropia refraction after LASIK', 'description': 'The main problem at young patients post - LASIK after one year is residual hypermetropic refractive errors (especially accommodation problem) The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual hypermetropic refractive error (min. +1.0D).\n\nThe flap of LASIk is lifted,cleaned and then the lenticule gently inserted.The lenticule was positioned according the K2 values when is astigmatism residual refractive error.In cases where is not astigmatism the lenticule was positioned in central position under the flap.', 'interventionNames': ['Device: ReLex Smile']}], 'interventions': [{'name': 'ReLex Smile', 'type': 'DEVICE', 'description': 'With the ReLex Smile the optical zone (lenticule diameter) and cap diameter are 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule is extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker (ViscotMedster).', 'armGroupLabels': ['Treatment of residual hypermetropia refraction after LASIK']}]}, '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'}}}}