Clinical Trial: Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
Brief Summary:
The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens with a refractive implant. Two colors of implants are available: white implants, filtering out ultraviolet and yellow implants, filtering and more blue light. No clinical data are available to assert the superiority of an implant according to its color and the choice is made according to the preference of the surgeon and / or "markets".
It is established in humans that blue light has an important role on the secretion of melanopsin, a key mediator of the circadian cycle. This "clock" regulates most neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the impact of these neuro endocrine functions of the installation of a blue light filter into the eyes of patients operated thus arises.
Detailed Summary:
Sponsor: University Hospital, Tours
Current Primary Outcome: Variation between before and 2 months after surgery sleep time [ Time Frame: 2 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Variation between before and 2 months after surgery the number of hours of sleep [ Time Frame: 2 months ]
- Variation between before and 2 months after surgery of the quality of sleep [ Time Frame: 2 months ]
- Variation between before and 2 months after surgery the mood evaluation score [ Time Frame: 2 months ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Tours
Dates:
Date Received: November 27, 2014
Date Started: December 2009
Date Completion:
Last Updated: February 23, 2017
Last Verified: February 2017
