Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:32 AM
Study NCT ID:
NCT07439835
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D064090', 'term': 'Intraocular Lymphoma'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007905', 'term': 'Lens 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': 'ACTUAL', 'count': 62}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected Visual Acuity assessment', 'timeFrame': '3 months postoperatively', 'description': 'Visual acuity assessment in 9 discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm) using the DDARTVC chart'}, {'measure': 'Area of the Visual Acuity Curve (AoC) assessment', 'timeFrame': '3 months postoperatively', 'description': 'Calculation of the AoC as a visual outcome measure'}, {'measure': 'Vision-Related Quality of Life', 'timeFrame': '3 months postoperatively', 'description': 'the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pseudophakic presbyopic correction', 'enhanced monofocal intraocular lens', 'defocus curves', 'visual curves', 'digital optotype'], 'conditions': ['Presbyopia', 'IOL, Cataract']}, 'referencesModule': {'references': [{'pmid': '41156017', 'type': 'BACKGROUND', 'citation': 'Labiris G, Panagis C, Mitsi C, Panagiotopoulou EK, Vorgiazidou E, Delibasis KK, Bakirtzis M. Enhancing Postoperative Evaluation of Presbyopia Corrections: Correlation of Visual Curve Indices with Vision-Related Quality of Life. J Clin Med. 2025 Oct 10;14(20):7149. doi: 10.3390/jcm14207149.'}, {'pmid': '36853857', 'type': 'BACKGROUND', 'citation': 'Labiris G, Panagiotopoulou EK, Delibasis K, Duzha E, Bakirtzis M, Panagis C, Boboridis K, Mokka A, Balidis M, Damtsi C, Ntonti P. Validation of a web-based distance visual acuity test. J Cataract Refract Surg. 2023 Jul 1;49(7):666-671. doi: 10.1097/j.jcrs.0000000000001176.'}, {'pmid': '37847127', 'type': 'BACKGROUND', 'citation': 'Labiris G, Panagis C, Ntonti P, Konstantinidis A, Bakirtzis M. Mix-and-match vs bilateral trifocal and bilateral EDOF intraocular lens implantation: the spline curve battle. J Cataract Refract Surg. 2024 Feb 1;50(2):167-173. doi: 10.1097/j.jcrs.0000000000001336.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate postoperative visual acuity curves in pseudophakic patients following unilateral or bilateral implantation of the enhanced monofocal TECNIS Eyhance IOL, using the DDARTVC.', 'detailedDescription': 'The present study aims to identify the exact points of the visual acuity curve, in which the enhanced monofocal TECNIS Eyhance IOL exhibit the optimal visual performance. Specifically, the study takes into account that the validated digital acuity chart DDARTVC assesses visual acuity under real-life conditions at nine discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm), rather than through simulated defocus values. Moreover, spline curve fitting was applied to the measured data points to generate continuous visual acuity curves, enabling estimation of visual performance across the full range of distances, rather than only at the predefined measurement points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Presbyopic patients who underwent pseudophakic presbyopic correction with the enhanced monofocal IOL Eyhance', 'healthyVolunteers': False, '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': 'NCT07439835', 'acronym': 'IOL-VAC', 'briefTitle': 'Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens: A Prospective Study', 'orgStudyIdInfo': {'id': 'ES3/Th5/03-02-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation', 'description': 'Patients who underwent uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \\& Johnson Vision, USA)', 'interventionNames': ['Procedure: Phacoemulsification with enhanced monofocal IOLs']}], 'interventions': [{'name': 'Phacoemulsification with enhanced monofocal IOLs', 'type': 'PROCEDURE', 'description': 'Uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \\& Johnson Vision, USA)', 'armGroupLabels': ['Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'facility': 'University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'overallOfficials': [{'name': 'Georgios Labiris, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}