Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-01 @ 9:27 PM
Study NCT ID:
NCT05944757
Status:
UNKNOWN
Last Update Posted:
2023-07-13
First Post:
2022-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Both models participated in this study.Models aged were from 20 up to 70'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2022-02-27', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improving dry eye symptoms', 'timeFrame': '12 months', 'description': 'hange From Baseline in Ocular Surface Staining \\['}], 'secondaryOutcomes': [{'measure': 'Improving corneal transparency', 'timeFrame': '12 months', 'description': 'Change From Baseline in Ocular Surface Disease Index (OSDI) The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye.\n\nThe total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRP', 'Dry Eye', 'Keratoconus', 'Dystrophy', 'Regenerative therapy'], 'conditions': ['PRP']}, 'descriptionModule': {'briefSummary': 'Platelet-rich plasma (PRP) is an autologous blood product rich in proteins and growth factors. Its application has been the subject of many studies in the field of ophthalmology to stimulate tissue healing and regeneration. Due to its anatomical features (lack of blood vessels), the cornea is among the most susceptible to damage structures of the eye. Therefore, the study of the impact of various regenerative therapies (autologous blood products, serums, ) on corneal lesions is important not only scientifically, but also practically for ophthalmologist. Numerous reports described the healing effect of PRP on corneal lesions.', 'detailedDescription': 'Purpose The objective of the study is to compare the efficacy of 100% prp autolog serum eye drops with 100 % of intrastromal injection-rich plateles plasma autolog serum eye drops in patients with moderate to severe dry eye in keratoconus disease,corneal dystrophy,chemical burns.\n\nMethods A total of 40 eyes were included in this prospective study. Clinical records of 20 consecutive patients with dry eye disease who had been treated with conventional autolog eye drops via intrastromal injection(conventional treatment group) and 20 consecutive patients treated with intrastromal autologous PRP eye drops i(PRP eye drops treated group) from September 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry eye diseases from other conditions( diabetes,allergy,keratoconus and others)\n* Corneal dystrophy\n* Chemical burns\n* Keratoconus\n\nExclusion Criteria:\n\n* Hemoglobin saturation (less than 11 mg/dl);\n* hepatopathies;\n* nephropathies;\n* coagulopathies;\n* hemoglobinopathies;\n* decompensated heart diseases;\n* infectious diseases such as Chagas, syphilis, HIV, HTLV, hepatitis B and C, and others transmissible by blood considered.'}, 'identificationModule': {'nctId': 'NCT05944757', 'acronym': 'prp', 'briefTitle': 'Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Eye Hospital Pristina Kosovo'}, 'officialTitle': 'Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions', 'orgStudyIdInfo': {'id': 'Anita Syla 1983'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP -plasma rich platelets group', 'description': 'Twenty patients (20) underwent 0.5 ml intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month', 'interventionNames': ['Drug: PRP plasma rich platelets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Autologous serum group', 'description': 'Twenty patients (20) underwent intrastromal injection of 0.5 ml of autologous serum (second group) every 2 weeks for 1 month', 'interventionNames': ['Drug: Autologous serum']}], 'interventions': [{'name': 'PRP plasma rich platelets', 'type': 'DRUG', 'otherNames': ['PRP'], 'description': 'Twenty patients (20) underwent 0.5 ml 100 % intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month', 'armGroupLabels': ['PRP -plasma rich platelets group']}, {'name': 'Autologous serum', 'type': 'DRUG', 'otherNames': ['AS'], 'description': 'Twenty patients (20) underwent intrastromal injection of 0.5 ml 100 %of autologous serum (second group) every 2 weeks for 1 month', 'armGroupLabels': ['Autologous serum group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Pristina', 'country': 'Kosovo', 'facility': 'Eye Hospital,University Center Clinic of Kosova', 'geoPoint': {'lat': 42.67272, 'lon': 21.16688}}], 'overallOfficials': [{'name': 'Anita Syla Lokaj', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Hospital,Univeristy Center Clinic of Kosova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anita Syla Lokaj', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator Faruk Semiz', 'investigatorFullName': 'Anita Syla Lokaj', 'investigatorAffiliation': 'Eye Hospital Pristina Kosovo'}}}}