NCT02593669|UnknownDMC
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Sponsor study identifier
interventional
10,000
1 country
1
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2015
Actual (reported)November 2, 2015
Actual (reported)January 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change from Post-illumination pupil response (PIPR)
3 months before the surgery and 3 months after the surgery
Change from Objective sleep quality:actigraphy
3 months before the surgery and 3 months after the surgery
Change from Subjective sleep quality: PSQI
3 months before the surgery and 3 months after the surgery
Phacoemulsification cataract surgery is performed with neutral IOL implantation.
Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.
The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation
The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Administration procedure
Subconjunctival dexamethasone and general anesthesia
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordZhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
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.
Haotian Lin, M.D., Ph.D
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
First Submitted
October 28, 2015
First Posted
November 2, 2015
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
viscoelastic materials are used to protect corneal endothelial cells.
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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.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 2, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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