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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Other: white implant; Other: yellow implant

• Registration Number: NCT02304900
• Lead Sponsor: University Hospital, Tours

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 Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-11-27
• Study First Posted: 2014-12-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• female or male subject
• subject between 60 and 90 years old
• Visual acuteness < or = with 2 eyes
• Indication operating of the cataract

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 : white implant	white implant	Randomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know.
Group 2 : yellow implant	yellow implant	Randomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know.

Primary Outcome Measures

Name	Time	Method
Variation between before and 2 months after surgery sleep time	2 months

Secondary Outcome Measures

Name	Time	Method
Variation between before and 2 months after surgery of the quality of sleep	2 months
Variation between before and 2 months after surgery the mood evaluation score	2 months
Variation between before and 2 months after surgery the number of hours of sleep	2 months

Trial Locations

Locations (2)

Service d'Ophtalmologie; 🇫🇷 Tours, France

Service d'Ophtalmologie, Centre Hospitalier Paul Martinais; 🇫🇷 Loches, France