Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT01605058
Status:
UNKNOWN
Last Update Posted:
2012-05-30
First Post:
2012-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Performance With a Trifocal Intraocular Lens
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-25', 'studyFirstSubmitDate': '2012-05-22', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity.\n\nPatient satisfaction and quality of vision will also be assessed by way of a questionnaire.', 'detailedDescription': 'Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2).\n\nSubjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near.\n\nDefocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted.\n\nContrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart.\n\nNear and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from a private ophthalmology clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-70yrs\n* Bilateral implantation of a trifocal intraocular lens\n\nExclusion Criteria:\n\n* existing ocular pathology\n* surgical complications\n* corneal astigmatism \\> 1.50DC'}, 'identificationModule': {'nctId': 'NCT01605058', 'briefTitle': 'Visual Performance With a Trifocal Intraocular Lens', 'organization': {'class': 'OTHER', 'fullName': 'BMI Southend Hospital'}, 'officialTitle': 'Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens', 'orgStudyIdInfo': {'id': 'TRI 1.1'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SS0 9AG', 'city': 'Westclifff-on-Sea', 'state': 'Essex', 'country': 'United Kingdom', 'contacts': [{'name': 'Elizabeth Agrippa', 'role': 'CONTACT', 'email': 'elizabeth.agrippa@gmail.com', 'phone': '07795176257'}], 'facility': 'BMI Southend Hospital'}], 'overallOfficials': [{'name': 'Elizabeth M Agrippa, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BMI Southend'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BMI Southend Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Optometrist', 'investigatorFullName': 'Elizabeth Agrippa', 'investigatorAffiliation': 'BMI Southend Hospital'}}}}