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

February 23, 2017 updated by: University Hospital, Tours

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • Service d'Ophtalmologie
      • Loches, France, 37600
        • Service d'Ophtalmologie, Centre Hospitalier Paul Martinais
      • Tours, France, 37
        • Service d'Ophtalmologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 : 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.
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
Experimental: Group 2 : 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation between before and 2 months after surgery sleep time
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation between before and 2 months after surgery the number of hours of sleep
Time Frame: 2 months
2 months
Variation between before and 2 months after surgery of the quality of sleep
Time Frame: 2 months
2 months
Variation between before and 2 months after surgery the mood evaluation score
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRI09-PJP / IOL et sommeil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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