Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02164994
Status:
UNKNOWN
Last Update Posted:
2015-04-24
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2014-06-13', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative keratometric cylinder', 'timeFrame': '18 months after the VICTUS femtosecond laser-assisted arcuate incisions.', 'description': 'Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes'}], 'secondaryOutcomes': [{'measure': 'Postoperative Manifest Cylinder', 'timeFrame': '19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.', 'description': 'Postoperative Manifest Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes'}, {'measure': 'Postoperative Objective Cylinder', 'timeFrame': '18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment.', 'description': 'Postoperative Objective Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Astigmatism, arcuate incisions, astigmatic keratotomy'], 'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.', 'detailedDescription': 'The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.\n\nThis study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.\n\nPatients will be recruited according to the study inclusion/exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Only the patients who were previously treated with VICTUS™ femtosecond laser-assisted arcuate incisions and successfully pass the eligibility criteria are eligible for this follow-up extension study.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clear corneal media\n* Patients must be at least 40 years of age\n* VICTUS™ femtosecond laser-assisted arcuate incisions surgery\n* Preoperative Keratometric astigmatism: ≥ 1.0D and ≤ 3D\n* Patients must have read, understood the Patient Information and signed the informed consent form\n* Patients are willing and able to return for follow-up examinations\n\nExclusion Criteria:\n\n* Corneal disease or pathology, such as corneal scaring\n* Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally\n* Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.\n* Manifest Glaucoma\n* Known sensitivity to planned concomitant medications\n* Patients regularly taking medicines that could influence the result of the treatment respectively the vision\n* Patients with disorders of the ocular muscle, such as nystagmus or strabismus\n* Patients with keratoconus, keratectasia or other irregular cornea changes\n* Patients with connective tissue weakness\n* Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.\n* Abnormal examination results from slit lamp, fundus examination or IOLMaster; age related changes are acceptable\n* Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic retinopathy\n* Abnormal examination results from topography, age related changes are acceptable\n* Patients who are pregnant or nursing\n* Patients with concentration disorders, epilepsy and other complicating diseases\n* Patients who are participating in another clinical study 30 days before"}, 'identificationModule': {'nctId': 'NCT02164994', 'briefTitle': 'Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Technolas Perfect Vision GmbH'}, 'officialTitle': 'Prospective Evaluation of the Long-term (18 Months) Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions Following Cataract Surgery', 'orgStudyIdInfo': {'id': '1402'}}, 'contactsLocationsModule': {'locations': [{'zip': '76001', 'city': 'Zlín', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Pavel Stodulka, Dr. med, PhD', 'role': 'CONTACT', 'email': 'barinkova@gemini.cz', 'phone': '+420734575158'}, {'name': 'Eliška Bařinková', 'role': 'CONTACT', 'email': 'barinkova@gemini.cz', 'phone': '+420734575158'}, {'name': 'Pavel Stodulka, Dr. med, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gemini Eye Clinic', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}], 'centralContacts': [{'name': 'Pavel Stodulka, Dr. med, PhD', 'role': 'CONTACT', 'email': 'barinkova@gemini.cz', 'phone': '+420734575158'}], 'overallOfficials': [{'name': 'Pavel Stodulka, Dr. med, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gemini clinic, Zlin Pavel Stodulka, Dr. med Study Principal Investigator Gemini eye clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technolas Perfect Vision GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}