Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:46 AM
Study NCT ID:
NCT07404293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zero CDE Technique for Lens Removal During FLACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of cataract cases completed with Zero CDE', 'timeFrame': 'Intraoperative'}], 'secondaryOutcomes': [{'measure': 'Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case.', 'timeFrame': 'Intraoperative'}, {'measure': 'Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop.', 'timeFrame': 'Postoperative Day 1'}, {'measure': 'Among the cataract cases with zero CDE o % of cataract cases with CME at any time up to 3 months postop.', 'timeFrame': 'Postoperative 2 weeks, 1 month and 3 months'}, {'measure': 'Among the cases requiring CDE, the amount of phaco energy used', 'timeFrame': 'Intraoperative'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zero CDE technique', 'FLACS'], 'conditions': ['Cataract With a Nuclear Sclerosis Grade Between 1 to 3']}, 'descriptionModule': {'briefSummary': "The Zero CDE (cumulative dissipated energy) technique facilitates cataract removal with no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye. In the investigator's experience, this technique consistently shows a stable anterior chamber, a low complication rate, and a rapid return of vision following cataract surgery. This prospective study aims to document the outcomes with the zero CDE technique during femtosecond laser-assisted cataract surgery (FLACS)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over the age of 50 years with operable cataract of nuclear sclerosis grade 1 to 3 as measured by LOCS III grading system (patients with cortical or posterior subcapsular cataract of any grade will be eligible).\n* Patients must be able to provide written informed consent for participating in the study.\n* Preoperative best corrected visual acuity of 20/25 or worse.\n\nExclusion Criteria:\n\n* Patients with corneal edema, corneal guttata, pseudoexfoliation, zonular dialysis, or other ocular anomalies (e.g., inflammation, uveitis, previous trauma, suspected microbial infection, glaucoma, and macular disease).\n* Patients wearing soft contact lenses will need to discontinue lens wear for 2 weeks, and hard contact lens wearers for one month prior to intraocular lens measurements.\n* Women patients of childbearing potential.\n* Patients undergoing arcuate keratotomy or other combined surgery with cataract.'}, 'identificationModule': {'nctId': 'NCT07404293', 'briefTitle': 'Zero CDE Technique for Lens Removal During FLACS', 'organization': {'class': 'OTHER', 'fullName': 'Bochner Eye Institute'}, 'officialTitle': 'Zero CDE Technique for Lens Nucleus Removal During Femtosecond Laser-Assisted Cataract Surgery', 'orgStudyIdInfo': {'id': 'RS/2024/01 version 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cataract removal with Zero CDE technique', 'description': 'This is a single-arm, non-comparative, prospective study including cataract patients with a nuclear sclerosis grade between 1 to 3 who desire to undergo cataract surgery and IOL implantation at Bochner Eye Institute, Canada.', 'interventionNames': ['Procedure: Femtosecond laser-assisted cataract surgery using Zero CDE']}], 'interventions': [{'name': 'Femtosecond laser-assisted cataract surgery using Zero CDE', 'type': 'PROCEDURE', 'description': 'In this single-arm, non-comparative study, patients with cataract grade 1-3 (LOCS III nuclear sclerosis) will undergo cataract removal with the Zero CDE technique that involves no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye.', 'armGroupLabels': ['Cataract removal with Zero CDE technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5R1A9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Raymond Stein, MD, FRCSC', 'role': 'CONTACT', 'email': 'raymondmstein@gmail.com', 'phone': '416-569-3806'}], 'facility': 'Bochner Eye Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Raymond Stein, MD, FRCSC', 'role': 'CONTACT', 'email': 'raymondmstein@gmail.com', 'phone': '416-569-3806'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bochner Eye Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Raymond Stein', 'investigatorAffiliation': 'Bochner Eye Institute'}}}}