Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT07077967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-12', 'studyFirstSubmitDate': '2025-07-12', 'studyFirstSubmitQcDate': '2025-07-12', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum Required Illuminance Level (MRIL)', 'timeFrame': '6 months postoperatively', 'description': 'Minimum Required Illuminance Level (MRIL) (in lx) at which participants reach their optimal Uncorrected Distance Visual Acuity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pseudophakic presbyopic correction', 'EDOF intraocular lens', 'light intensity', 'eye light transmittance', 'light efficiency function'], 'conditions': ['Presbyopia']}, 'referencesModule': {'references': [{'pmid': '34866900', 'type': 'BACKGROUND', 'citation': 'Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective of this study is to introduce a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients who underwent pseudophakic presbyopic correction with extended-depth of focus (EDOF) intraocular lenses (IOLs) implantations.', 'detailedDescription': 'Present study aims to identify in which degree EDOF IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following pseudophakic presbyopic corrections implanted with EDOF IOLs. Specifically, the aim of this study is to identify the minimum light intensity at which patients who underwent pseudophakic presbyopic correction with EDOF IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Presbyopic patients who underwent pseudophakic presbyopic correction with EDOF intraocular lens implantation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 45 to 75 years\n\nExclusion Criteria:\n\n* astigmatism \\>1.00 diopters\n* glaucoma\n* former incisional eye surgery\n* corneal or fundus disease\n* diabetes mellitus\n* autoimmune diseases\n* neurological or psychiatric diseases\n* posterior capsule rupture or lens misalignment\n* postoperative uncorrected distance visual acuity \\< 8/10.'}, 'identificationModule': {'nctId': 'NCT07077967', 'acronym': "V(λ)'_EDOF", 'briefTitle': "Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs", 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': "Impact of Artificial Lighting on Visual Acuity After Presbyopia Correction With an Extended Depth of Focus Intraocular Lens: Introduction of a Modified Luminous Efficiency Function V(λ)'", 'orgStudyIdInfo': {'id': 'ES5/Th9/13-02-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients who underwent uneventful pseudophakic presbyopic correction with yellow filter extended depth-of-focus (EDOF) IOLs (Vivity or Vivity toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)', 'interventionNames': ['Procedure: Phacoemulsification with EDOF IOLs']}, {'label': 'Control group', 'description': 'Patients of similar age who underwent uneventful cataract surgery implanted with yellow filter monofocal or monofocal toric IOLs (SN60WF or SN6ATx, Alcon Laboratories, Inc., Fort Worth, TX, USA)'}], 'interventions': [{'name': 'Phacoemulsification with EDOF IOLs', 'type': 'PROCEDURE', 'description': 'Uneventful pseudophakic presbyopic correction with EDOF IOLs', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'contacts': [{'name': 'Dimitrios Aggelonias, MSc', 'role': 'CONTACT', 'email': 'dangelon@affil.duth.gr', 'phone': '+30 2551030990'}, {'name': 'Eirini - Kanella Panagiotopoulou', 'role': 'CONTACT', 'email': 'panagiotopoulou.ek@gmail.com'}, {'name': 'Eirini - Kanella Panagiotopoulou, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Alexandroupolis', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'centralContacts': [{'name': 'Eirini - Kanella Panagiotopoulou, MD, MSc, PhD', 'role': 'CONTACT', 'email': 'panagiotopoulou.ek@gmail.com', 'phone': '+30 6978730858'}, {'name': 'Georgios Labiris, MD, Prof', 'role': 'CONTACT', 'email': 'labiris@usa.net', 'phone': '+30 2551030990'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Ophthalmology', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}