Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-21 @ 1:24 AM
Study NCT ID:
NCT02315456
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2014-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019923', 'term': 'Capsulorhexis'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL', 'timeFrame': '10-30 days post surgery', 'description': 'The horizontal and vertical overlap will be calculated. Horizontal overlap= Overlap of the temporal half versus the nasal half Vertical overlap= overlap of the superior half versus the inferior half of the IOL.\n\nSymmetricity of overlap= Horizontal overlap/vertical overlap'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['capsulorhexis', 'IOL centration'], 'conditions': ['Capsulorhexis']}, 'referencesModule': {'references': [{'pmid': '17321392', 'type': 'BACKGROUND', 'citation': 'de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054.'}]}, 'descriptionModule': {'briefSummary': 'The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.', 'detailedDescription': '50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated.\n\nEach group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cataracts\n* Same variety of IOL inserted in all eyes\n\nExclusion Criteria:\n\n* Previous glaucoma or retinal surgery\n* Pupil not dilating beyond 6mm\n* Zonular weakness or pseudoexfoliation\n* Extensive corneal scarring\n* High refractive error: Myopia greater than 10D, Hyperopia greater than 5D'}, 'identificationModule': {'nctId': 'NCT02315456', 'briefTitle': 'Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser', 'orgStudyIdInfo': {'id': '1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Capsule centration', 'description': 'Capsulorhexis made with capsule centration', 'interventionNames': ['Procedure: capsulorhexis']}, {'type': 'OTHER', 'label': 'Pupil centration', 'description': 'Capsulorhexis made with pupil centration', 'interventionNames': ['Procedure: capsulorhexis']}], 'interventions': [{'name': 'capsulorhexis', 'type': 'PROCEDURE', 'armGroupLabels': ['Capsule centration', 'Pupil centration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Surendra Basti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'OptiMedica Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Ophthalmology', 'investigatorFullName': 'Surendra Basti', 'investigatorAffiliation': 'Northwestern University'}}}}