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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
white implant
yellow implant
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service d'Ophtalmologie
  • Service d'Ophtalmologie, Centre Hospitalier Paul Martinais
  • Service d'Ophtalmologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 : white implant

Group 2 : yellow implant

Arm 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.

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

Outcomes

Primary Outcome Measures

Variation between before and 2 months after surgery sleep time

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2014
Last Updated
February 23, 2017
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02304900
Brief Title
Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
Acronym
IOL et sommeil
Official Title
Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : white implant
Arm Type
Experimental
Arm 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.
Arm Title
Group 2 : yellow implant
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
white implant
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
yellow implant
Intervention Description
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
Primary Outcome Measure Information:
Title
Variation between before and 2 months after surgery sleep time
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Variation between before and 2 months after surgery the number of hours of sleep
Time Frame
2 months
Title
Variation between before and 2 months after surgery of the quality of sleep
Time Frame
2 months
Title
Variation between before and 2 months after surgery the mood evaluation score
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service d'Ophtalmologie
City
Brest
Country
France
Facility Name
Service d'Ophtalmologie, Centre Hospitalier Paul Martinais
City
Loches
ZIP/Postal Code
37600
Country
France
Facility Name
Service d'Ophtalmologie
City
Tours
ZIP/Postal Code
37
Country
France

12. IPD Sharing Statement

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

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