Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT05430295
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2022-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}, {'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-02', 'size': 453532, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-02T10:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective comparative interventional clinical study,'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-24', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-06-18', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected and best-corrected distance, and intermediate visual acuity.', 'timeFrame': '3 months post operative', 'description': 'Distance visual acuities were examined by ETDRS chart and intermediate and near visual acuity by Jaeger chart at 66 cm and 33 cm respectively.Measured values of the visual acuity were expressed in decimal values and converted to logMAR values.'}], 'secondaryOutcomes': [{'measure': 'Contrast sensitivity', 'timeFrame': '3 months post operative', 'description': 'Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['intraocular lens', 'intermediate vision', 'contrast sensitivity', 'monofocal'], 'conditions': ['Lenses, Intraocular']}, 'descriptionModule': {'briefSummary': 'This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.', 'detailedDescription': 'Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens.\n\nMethods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 50-75 years old undergoing cataract surgery.\n* Preoperative corneal astigmatism equal to or less than - 1.00 D.\n* Availability, willingness and sufficient cognitive awareness to comply with examination procedures\n\nExclusion Criteria:\n\n* Visual potential of less than 0.63 due to ocular pathologies.\n* Corneal astigmatism over -1.00 D cylinder.\n* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions).\n* Capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome.\n* Macular degeneration, cystoid macular edema,Diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.'}, 'identificationModule': {'nctId': 'NCT05430295', 'briefTitle': 'Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens', 'orgStudyIdInfo': {'id': 'MS-239-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eyhance intraocular lens', 'description': '10 patients bilaterally implanted with Eyhance intraocular lens', 'interventionNames': ['Procedure: phacoemulsification', 'Procedure: monofocal intraocular lens implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tecnis 1 piece intraocular lens', 'description': '10 patients bilaterally implanted with Tecnis 1 piece intraocular lens', 'interventionNames': ['Procedure: phacoemulsification', 'Procedure: monofocal intraocular lens implantation']}], 'interventions': [{'name': 'phacoemulsification', 'type': 'PROCEDURE', 'otherNames': ['cataract extraction'], 'description': 'cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients', 'armGroupLabels': ['Eyhance intraocular lens', 'Tecnis 1 piece intraocular lens']}, {'name': 'monofocal intraocular lens implantation', 'type': 'PROCEDURE', 'description': 'implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery', 'armGroupLabels': ['Eyhance intraocular lens', 'Tecnis 1 piece intraocular lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11555', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Kasraliany Hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'yehia Salaheldin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the data of the patients are kept in files with the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ophthalmology resident', 'investigatorFullName': 'Rokaya Emad Radwan', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}