Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-26 @ 6:18 PM
Study NCT ID:
NCT02492659
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2015-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research of Femtosecond Laser-Assisted Cataract Surgery
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'phacoemulsification energy', 'timeFrame': 'in operation'}, {'measure': 'phacoemulsification time', 'timeFrame': 'in operation'}, {'measure': 'postoperative refraction', 'timeFrame': 'day 1,after one week'}, {'measure': 'the capsulorhexis size', 'timeFrame': 'after one month,after three month'}, {'measure': 'corneal endothelial density', 'timeFrame': 'after one month,after three month'}], 'primaryOutcomes': [{'measure': 'the proteins in the aqueous humor after femtosecond laser operation', 'timeFrame': 'day 1'}], 'secondaryOutcomes': [{'measure': 'the electrolyte in the aqueous humor after femtosecond laser operation', 'timeFrame': 'day 1'}, {'measure': 'morphology of the anterior capsule after femtosecond laser operation', 'timeFrame': 'day 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['femtosecond laser'], 'conditions': ['Cataracts']}, 'descriptionModule': {'briefSummary': 'Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced phacoemulsification power and time, and comparable refractive outcome in clinic.\n\nIt is still unknown whether there are toxic substances produced due to photochemical or high-energy physical effect of femtosecond laser during FLACS.', 'detailedDescription': 'Phacoemulsification is one of the main surgical procedures for cataract surgery owing to the advantages of small incisions and rapid recovery. However, the surgical outcome of phacoemulsification can be negatively affected due to the problem of accuracy and repeatability for capsulorhexis, and the corneal endothelial cell damage by ultrasound energy.To overcome those problems from the phacoemulsification, femtosecond laser-assisted cataract surgery (FLACS) had been used in the past few years and showed unique advantages.\n\nThe purpose of this study is to investigate the preliminary clinical outcomes of femtosecond laser-assisted cataract surgery.This prospective comparative study enrolled consecutive patients,will be randomly assigned to trial group underwent FLACS and control group underwent conventional cataract surgery.\n\nThe phacoemulsification time, energy, and complications during operation were recorded.\n\nThe anterior capsule and aqueous humor were collected. Morphology of the cutting edge and cells of anterior capsule was assessed by light microscopy. The proteins in the aqueous humor were identified by mass spectrometry . Electrolyte in the aqueous humor was detected by a chemistry analyzer. Postoperative refraction at 1 day, 1 week, 1 and 3 months, the capsulorhexis size and corneal endothelial density at 1 and 3 months were also measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '38 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. normal cornea\n2. dilated pupillary diameter greater than 6mm\n3. no local or systemic contraindications to cataract surgery\n\nExclusion Criteria:\n\n1. corneal pathological changes\n2. glaucoma\n3. ocular inflammation\n4. previous ocular trauma or surgery'}, 'identificationModule': {'nctId': 'NCT02492659', 'acronym': 'FLACS', 'briefTitle': 'Clinical Research of Femtosecond Laser-Assisted Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Clinical Research of Femtosecond Laser-Assisted Cataract Surgery: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Femtosecond Laser'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'trial group', 'description': 'the trial group underwent femtosecond laser-assisted cataract surgery', 'interventionNames': ['Procedure: femtosecond laser-assisted cataract surgery']}, {'type': 'OTHER', 'label': 'control group', 'description': 'the control group underwent conventional phacoemulsification', 'interventionNames': ['Procedure: conventional phacoemulsification']}], 'interventions': [{'name': 'femtosecond laser-assisted cataract surgery', 'type': 'PROCEDURE', 'description': 'the femtosecond laser platform was used to generate capsulotomy with a diameter as described above in the control group, and lens fragmentation into 6 segments.', 'armGroupLabels': ['trial group']}, {'name': 'conventional phacoemulsification', 'type': 'PROCEDURE', 'description': 'continuous curvilinear capsulorhexis was performed with capsulorrhexis forceps. Following hydrodissection, phacoemulsification of the nucleus, aspiration of the residual cortex and capsular polishing were performed using a phacoemulsification machine', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Eye Hispital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'A-Yong Yu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'A-Yong Yu', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}