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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Other: white implant
* Other: yellow implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 : white implant<br>Randomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know. | Other: white implant<br>* st intervention (in the month following the inclusion): Randomization of the color of the implant nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye<br>|
| Experimental: Group 2 : yellow implant<br>Randomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know. | Other: yellow implant<br>* st intervention (in the month following the inclusion): Randomization of the color of the implant nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation between before and 2 months after surgery sleep time |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation between before and 2 months after surgery the number of hours of sleep |  | 2 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract