Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT02264457
Status:
UNKNOWN
Last Update Posted:
2019-01-23
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-corrected visual acuity', 'timeFrame': 'Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months'}], 'secondaryOutcomes': [{'measure': 'Manifest refraction', 'timeFrame': 'Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)'}, {'measure': 'Rotational stability', 'timeFrame': 'Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)'}, {'measure': 'IOL centration', 'timeFrame': 'Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)'}, {'measure': 'Prevalence of posterior capsular Opacification', 'timeFrame': 'visit 4 (3-4 months)'}]}, 'conditionsModule': {'keywords': ['Lenses, Intraocular'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. If left uncorrected the astigmatism would mean that you would need to wear spectacles for viewing distance objects. New IOL designs called toric IOLs help to correct the astigmatism to improve your vision after cataract surgery. This study has been designed to look at how well a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing distance objects. There are many designs of these toric IOLs and for this study we are looking to compare two different designs of toric IOLs by putting one lens in your right eye and a different type of lens in your left eye. Both lenses are commercially available and are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge the visual performance of these lenses and the ability of these lenses to correct astigmatism. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-75 years, bilateral significant corneal astigmatism \\>1.50D.\n* Requiring a Toric IOL within the following power range:\n* Sphere +6.00D to +30.00D\n* Cylinder +1.00D to +6.00D\n\nExclusion Criteria:\n\n* Amblyopia,\n* predicted bilateral post-op corneal astigmatism of \\<1.50D,\n* irregular astigmatism,\n* dilated pupil size smaller than 5mm,\n* macular pathology,\n* glaucoma,\n* retinal disease,\n* corneal disease,\n* abnormal iris,\n* pupil deformation and\n* any previous corneal or intraocular surgery.'}, 'identificationModule': {'nctId': 'NCT02264457', 'briefTitle': 'A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses', 'organization': {'class': 'OTHER', 'fullName': 'University of Plymouth'}, 'officialTitle': 'A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism', 'orgStudyIdInfo': {'id': 'IISR-2014-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'First eye closed loop haptic', 'description': 'subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery', 'interventionNames': ['Device: T-flex Aspheric Toric IOL', 'Device: AT TORBI toric IOL']}, {'type': 'OTHER', 'label': 'First eye plate haptic', 'description': 'subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery', 'interventionNames': ['Device: T-flex Aspheric Toric IOL', 'Device: AT TORBI toric IOL']}], 'interventions': [{'name': 'T-flex Aspheric Toric IOL', 'type': 'DEVICE', 'armGroupLabels': ['First eye closed loop haptic', 'First eye plate haptic']}, {'name': 'AT TORBI toric IOL', 'type': 'DEVICE', 'armGroupLabels': ['First eye closed loop haptic', 'First eye plate haptic']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS09AG', 'city': 'Westcliff-on-Sea', 'state': 'Essex', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Maralyn Cole', 'role': 'CONTACT', 'email': 'Maralyn.Cole@bmihealthcare.co.uk', 'phone': '01702 608908'}, {'name': 'Elizabeth Law, BSc(hons)', 'role': 'CONTACT', 'email': 'elizabeth.law@plymouth.ac.uk'}], 'facility': 'BMI Southend Private Hospital', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}], 'centralContacts': [{'name': 'Phillip J Buckhurst, PhD', 'role': 'CONTACT', 'email': 'phillip.buckhurst@plymouth.ac.uk', 'phone': '+44 (0) 1752 588884'}], 'overallOfficials': [{'name': 'Phillip J Buckhurst, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Plymouth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Plymouth', 'class': 'OTHER'}, 'collaborators': [{'name': 'BMI Southend Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (Senior Lecturer)', 'investigatorFullName': 'Dr Phillip J Buckhurst', 'investigatorAffiliation': 'University of Plymouth'}}}}