Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-26 @ 2:11 PM
Study NCT ID:
NCT06267495
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094504', 'term': 'Corneal Cross-Linking'}], 'ancestors': [{'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steep keratometry value', 'timeFrame': '24 months', 'description': 'The steep keratometry is measured using pentacam. A higher value means a worse outcome.'}, {'measure': 'Maximum keratometry value', 'timeFrame': '24 months', 'description': 'The maximum keratometry is measured using pentacam. A higher value means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Corrected distance visual acuity', 'timeFrame': '24 months', 'description': "Corrected distance visual acuity (CDVA) is measured with Snellen's acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) notation.\n\nThe higher the logMAR CDVA, the worse the outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keratoconus', 'Corneal cross-linking', 'Epithelium-on CXL'], 'conditions': ['Keratoconus']}, 'referencesModule': {'references': [{'pmid': '30702472', 'type': 'BACKGROUND', 'citation': 'Koh S, Inoue R, Maeda N, Kabata D, Shintani A, Jhanji V, Klyce SD, Maruyama K, Nishida K. Long-term Chronological Changes in Very Asymmetric Keratoconus. Cornea. 2019 May;38(5):605-611. doi: 10.1097/ICO.0000000000001890.'}, {'pmid': '32267959', 'type': 'BACKGROUND', 'citation': 'Henriquez MA, Hadid M, Izquierdo L Jr. A Systematic Review of Subclinical Keratoconus and Forme Fruste Keratoconus. J Refract Surg. 2020 Apr 1;36(4):270-279. doi: 10.3928/1081597X-20200212-03.'}]}, 'descriptionModule': {'briefSummary': 'Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.\n\nThe aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only.', 'detailedDescription': 'Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion with resultant irregular astigmatism and visual loss.\n\nAlthough several studies showed that epithelium-off corneal cross-linking (epi-off CXL) is more effective in preventing KC progression compared with epithelium-on corneal cross-linking (epi-on CXL), the removal of corneal epithelium in epi-off CXL might be associated with a number of serious complications such as persistent epithelial defects and sight-threatening infectious keratitis. Additionally, recent systematic reviews and meta-analysis concluded that epi-on CXL is as effective as epi-off CXL in terms of visual and topographic stability of keratoconus, but has the advantage of being much safer avoiding the complications of epithelial removal.\n\nThe management of the better eye, of young patients with unilateral clinically evident KC, is controversial. Some ophthalmologists prefer to cross-link the better eye, while others prefer to conservatively follow it up, in order to avoid complications of epithelial removal in epi-off CXL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective comparative study was conducted at a refractive and corneal surgery center in Assiut (Private practice). The study included young patients who were diagnosed with forme fruste or subclinical keratoconus.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 12 to 30 years presented with forme fruste (FFKC) or subclinical KC, based on the following criteria:\n\n1. Normal slit lamp examination\n2. Normal topography in FFKC and suspicious topography in subclinical KC with asymmetric bow-tie or inferior steeping (inferior-superior value less than 1.40 D in the anterior sagittal curvature map in pentacam)\n3. Clinical and topographic features of KC in the other eye.\n\nExclusion Criteria:\n\n1. Corrected distance visual acuity (CDVA) worse than 0.1 logMAR\n2. Corneal thickness at the thinnest location less than 400 μm\n3. Severe ocular allergy (active catarrhal keratoconjunctivitis)\n4. Other corneal or ocular diseases\n5. Systemic diseases such as diabetes mellitus and autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT06267495', 'briefTitle': 'Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Epithelium-on Accelerated Corneal Cross-linking Versus Observation of Fellow Eyes of Young Patients With Unilateral Clinically Evident Keratoconus', 'orgStudyIdInfo': {'id': 'EOCXLFE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epithelium-on corneal cross-linking group', 'description': 'Patients in this group underwent epithelium-on accelerated corneal cross-linking (epi-on CXL) for the eye with no clinical signs of keratoconus.', 'interventionNames': ['Procedure: Epithelium-on corneal cross-linking (epi-on CXL)']}, {'label': 'Follow-up group', 'description': 'Patients in this group were planned to have regular follow-up visits, without intervention, for the eye with no clinical signs of keratoconus.'}], 'interventions': [{'name': 'Epithelium-on corneal cross-linking (epi-on CXL)', 'type': 'PROCEDURE', 'description': 'In epithelium-on corneal cross-linking (epi-on CXL), the cornea is soaked with riboflavin for 10 minutes (Paracel® for 4 minutes and VibeX-xtra® for 6 minutes) . Thereafter, the cornea is subjected to ultraviolet A at a wavelength of 370 nm to give a total dose of 5.4 J/cm² through 10 milliwatt mW/cm² for 9 minutes.', 'armGroupLabels': ['Epithelium-on corneal cross-linking group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71516', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Tiba Eye Center', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mahmoud Abdel-Radi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mahmoud Abdel-Radi', 'investigatorAffiliation': 'Assiut University'}}}}