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OpenTrials
Completed

NCT Number: NCT02304900

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

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.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Ophtalmologie, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

white implant

Other
  • 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

yellow implant

Other
  • 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 outcomes

  1. Variation between before and 2 months after surgery sleep time

    Time frame: 2 months

Secondary outcomes

  1. Variation between before and 2 months after surgery the number of hours of sleep

    Time frame: 2 months

  2. Variation between before and 2 months after surgery of the quality of sleep

    Time frame: 2 months

  3. Variation between before and 2 months after surgery the mood evaluation score

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: IOL et sommeil

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 2, 2014
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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