Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07092020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EDF IOL Versus Monofocal IOL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean monocular DCIVA at 66 cm', 'timeFrame': '6 Months'}, {'measure': 'Mean monocular CDVA at 4 m', 'timeFrame': '6 Months'}, {'measure': 'Mean monocular DCVA at 1 m (equal to -1 D defocus)', 'timeFrame': '6 Months'}, {'measure': 'Mean monocular negative defocus range at the 0.20 logMAR compared to control', 'timeFrame': '6 Months'}, {'measure': 'Proportion of eyes achieving monocular photopic CDVA 0.30 logMAR or better', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome (PRO)', 'timeFrame': '6 Months', 'description': 'Proportion of subjects who respond "I didn\'t wear glasses or contact lenses at all in the last 7 days" to question "How often did you wear glasses or contact lenses to see in the last 7 days?" from Patient Reported Outcome (PRO) survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IOL', 'Cataract'], 'conditions': ['Cataract Senile']}, 'descriptionModule': {'briefSummary': 'EDF intraocular lens versus Monofocal intraocular lens', 'detailedDescription': 'Extended depth of Focus intraocular lens versus a monofocal intraocular lens'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients of any gender, aged 18 years or older\n2. Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement\n3. Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)\n4. Calculated lens power within the available range\n5. Clear intraocular media other than cataract\n6. Patient is willing and capable of providing informed consent\n7. Patient is willing and capable of complying with visits and procedures as defined by this protocol\n\nExclusion Criteria:\n\n1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)\n2. Endothelial cell count of less than 2000/mm2\n3. Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.\n4. Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study\n5. Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia\n6. Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.)\n7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)\n8. Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study\n9. Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk\n10. Clinically significant gonioscopic abnormalities\n11. Amblyopia, strabismus, single eye status\n12. Rubella, congenital, traumatic or complicated cataracts\n13. History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis\n14. Microphthalmos or macrophthalmos\n15. Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)\n16. Pseudoexfoliation\n17. Keratoconus or irregular astigmatism\n18. Inability to measure keratometry or biometry (including but not limited to cataract density, etc.)\n19. Pathologic miosis\n20. Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes\n21. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial\n22. Patients whose freedom is impaired by administrative or legal order\n23. Concurrent participation in another clinical investigation in the last 30 days."}, 'identificationModule': {'nctId': 'NCT07092020', 'briefTitle': 'EDF IOL Versus Monofocal IOL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec AG'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Observer-masked, Multi-center Clinical Trial to Demonstrate the Safety and Effectiveness of the Extended Depth of Focus AT LARA 829MP Posterior Chamber Intraocular Lens for Correction of Aphakia', 'orgStudyIdInfo': {'id': 'AT LARA 829MP BER-401-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EDF', 'description': 'Extended depth of focus', 'interventionNames': ['Device: EDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monofocal', 'description': 'Monofocal', 'interventionNames': ['Device: Monofocal IOL']}], 'interventions': [{'name': 'EDF', 'type': 'DEVICE', 'description': 'Extended depth of focus', 'armGroupLabels': ['EDF']}, {'name': 'Monofocal IOL', 'type': 'DEVICE', 'description': 'Monofocal', 'armGroupLabels': ['Monofocal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Eye Hospital Zora', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Specialized Ophthalmological Hospital for Active Treatment', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Stara Zagora', 'country': 'Bulgaria', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Medical Center "Vereya"', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'city': 'Havlíčkův Brod', 'country': 'Czechia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Nemocnice Havlíčkův', 'geoPoint': {'lat': 49.6069, 'lon': 15.57937}}, {'city': 'Pardubice', 'country': 'Czechia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'OFTEX ocni', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Oční Centrum', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Oculus Eye Clinic', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Sibiu', 'country': 'Romania', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Ofta Total Clinic', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Suceava', 'country': 'Romania', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Medoptic Clinic', 'geoPoint': {'lat': 47.63333, 'lon': 26.25}}, {'city': 'Alicante', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Oftalvist', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Sant Cugat del Vallès', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'OMIQ Hospital Universitari', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'University Hopital Complex of Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Valencia', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Oftalvist', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Carl Zeiss Meditec AG', 'role': 'CONTACT', 'email': 'info@zeiss.com', 'phone': '+49308540010'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}