Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10000 participants
INTERVENTIONAL
2016-01-31
2018-12-31
Brief Summary
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Detailed Description
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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. Patients enrolled into the study will be assessed in 3 months before the surgery and 3 months after the surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Neutral IOL
Phacoemulsification cataract surgery is performed with neutral IOL implantation.
Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation
Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Viscoelastic materials
viscoelastic materials are used to protect corneal endothelial cells.
Blue-blocking IOL
Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.
Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.
Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Viscoelastic materials
viscoelastic materials are used to protect corneal endothelial cells.
Interventions
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Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation
Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.
Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Viscoelastic materials
viscoelastic materials are used to protect corneal endothelial cells.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe systemic disease: Diabetes, Sleep disorder.et.al
* Vision-impairing complications: Ruptured posterior capsule, Persistent cornea edema.et.al
ALL
No
Sponsors
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Ministry of Health, China
OTHER_GOV
Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center
Principal Investigators
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Haotian Lin, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D.
Role: STUDY_DIRECTOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Facility Contacts
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References
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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.
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.
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.
Related Links
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Description Home page of Zhongshan Ophthalmic Center
Other Identifiers
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CCPMOH2010-China8
Identifier Type: -
Identifier Source: org_study_id
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