NCT02304900

Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
OTHER	white implant	1. st intervention (in the month following the inclusion): Randomization of the color of the implant 2. nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye
OTHER	yellow implant	1. st intervention (in the month following the inclusion): Randomization of the color of the implant 2. nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2014-12-02
• Last updated: 2025-12-22

Locations

3 sites across 1 country: France