Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT02593669
Status:
UNKNOWN
Last Update Posted:
2015-11-02
First Post:
2015-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cataract Surgery on Sleep Quality
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004343', 'term': 'Drug Implants'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Post-illumination pupil response (PIPR)', 'timeFrame': '3 months before the surgery and 3 months after the surgery'}, {'measure': 'Change from Objective sleep quality:actigraphy', 'timeFrame': '3 months before the surgery and 3 months after the surgery'}, {'measure': 'Change from Subjective sleep quality: PSQI', 'timeFrame': '3 months before the surgery and 3 months after the surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cataract', 'Sleep']}, 'referencesModule': {'references': [{'pmid': '26233628', 'type': 'BACKGROUND', 'citation': 'Brondsted AE, Sander B, Haargaard B, Lund-Andersen H, Jennum P, Gammeltoft S, Kessel L. The Effect of Cataract Surgery on Circadian Photoentrainment: A Randomized Trial of Blue-Blocking versus Neutral Intraocular Lenses. Ophthalmology. 2015 Oct;122(10):2115-24. doi: 10.1016/j.ophtha.2015.06.033. Epub 2015 Jul 30.'}, {'pmid': '24701992', 'type': 'BACKGROUND', 'citation': 'Ayaki M, Negishi K, Tsubota K. Rejuvenation effects of cataract surgery with ultraviolet blocking intra-ocular lens on circadian rhythm and gait speed. Rejuvenation Res. 2014 Aug;17(4):359-65. doi: 10.1089/rej.2014.1550.'}, {'pmid': '23145881', 'type': 'BACKGROUND', 'citation': 'Ayaki M, Muramatsu M, Negishi K, Tsubota K. Improvements in sleep quality and gait speed after cataract surgery. Rejuvenation Res. 2013 Feb;16(1):35-42. doi: 10.1089/rej.2012.1369.'}], 'seeAlsoLinks': [{'url': 'http://www.gzzoc.com/', 'label': 'Description Home page of Zhongshan Ophthalmic Center'}]}, 'descriptionModule': {'briefSummary': 'A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in vision. It is the most prevalent, treatable cause of visual impairment and blindness in the world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and thought to be the most effective surgical procedure in any field of medicine. In this trial, the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and sleep as well as the effect of the blue light transmission characteristics of the implanted IOL on sleep.', 'detailedDescription': 'A Prospective, randomized controlled study of 10000 participants(20000 eyes) with dense nucleus were enrolled. Patients were assigned to two groups: Group I: neutral IOL implanted in eye while in Group II, blue-blocking IOL was innovatively implanted in the eye.\n\nA cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in vision. It is the most prevalent, treatable cause of visual impairment and blindness in the world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and thought to be the most effective surgical procedure in any field of medicine.\n\nIn this trial, the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and sleep as well as the effect of the blue light transmission characteristics of the implanted IOL on sleep. Patients enrolled into the study will be assessed in 3 months before the surgery and 3 months after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral age-related cataract scheduled for cataract surgery\n\nExclusion Criteria:\n\n* Vision-impairing ophthalmic disease: Glaucoma, AMD, DR.et.al\n* Severe systemic disease: Diabetes, Sleep disorder.et.al\n* Vision-impairing complications: Ruptured posterior capsule, Persistent cornea edema.et.al'}, 'identificationModule': {'nctId': 'NCT02593669', 'briefTitle': 'The Effect of Cataract Surgery on Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Effect of Cataract Surgery for Age-related Cataract Patients on Circadian Rhythm and Sleep Quality', 'orgStudyIdInfo': {'id': 'CCPMOH2010-China8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neutral IOL', 'description': 'Phacoemulsification cataract surgery is performed with neutral IOL implantation.', 'interventionNames': ['Procedure: Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation', 'Drug: Subconjunctival dexamethasone and general anesthesia', 'Drug: Viscoelastic materials']}, {'type': 'EXPERIMENTAL', 'label': 'Blue-blocking IOL', 'description': 'Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.', 'interventionNames': ['Procedure: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation', 'Drug: Subconjunctival dexamethasone and general anesthesia', 'Drug: Viscoelastic materials']}], 'interventions': [{'name': 'Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation', 'type': 'PROCEDURE', 'description': 'The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation', 'armGroupLabels': ['Neutral IOL']}, {'name': 'Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation', 'type': 'PROCEDURE', 'description': 'The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.', 'armGroupLabels': ['Blue-blocking IOL']}, {'name': 'Subconjunctival dexamethasone and general anesthesia', 'type': 'DRUG', 'description': 'All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.', 'armGroupLabels': ['Blue-blocking IOL', 'Neutral IOL']}, {'name': 'Viscoelastic materials', 'type': 'DRUG', 'description': 'viscoelastic materials are used to protect corneal endothelial cells.', 'armGroupLabels': ['Blue-blocking IOL', 'Neutral IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Haotian Lin, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'haot.lin@hotmail.com', 'phone': '8613802793086'}, {'name': 'Jing Li, M.D.', 'role': 'CONTACT', 'email': 'Reviewborad_SYsU@163.com', 'phone': '+86-20-87330341'}], 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Haotian Lin, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Yizhi Liu, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Weirong Chen, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center', 'investigatorFullName': 'Haotian Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}