Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep (IOL et sommeil)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Cataract

Treatments: Other: white implant; Other: yellow implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02304900

PHRI09-PJP / IOL et sommeil

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Group 1 : white implant

Experimental group

Description:

Randomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know.

Treatment:

Other: white implant

Group 2 : yellow implant

Experimental group

Description:

Randomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know.

Treatment:

Other: yellow implant