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

NCT02304900 | Completed

• 1 other identifier: PHRI09-PJP / IOL et sommeil
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

Cataract

Keywords

cataract

Outcome Measures

Primary Outcomes (1)

• Variation between before and 2 months after surgery sleep time

  2 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Group 1 : white implant

EXPERIMENTAL

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

Group 2 : yellow implant

EXPERIMENTAL

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

Interventions

yellow implant OTHER

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

Group 2 : yellow implant

white implant OTHER

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

Group 1 : white implant

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female or male subject
• subject between 60 and 90 years old
• Visual acuteness \< or = with 2 eyes
• Indication operating of the cataract

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

Service d'Ophtalmologie

Brest, France

Location

Service d'Ophtalmologie, Centre Hospitalier Paul Martinais

Loches, 37600, France

Location

Service d'Ophtalmologie

Tours, 37, France

Location

Related Publications (1)

• Zambrowski O, Tavernier E, Souied EH, Desmidt T, Le Gouge A, Bellicaud D, Cochener B, Limousin N, Hommet C, Autret-Leca E, Pisella PJ, Camus V. Sleep and mood changes in advanced age after blue-blocking (yellow) intra ocular lens (IOLs) implantation during cataract surgical treatment: a randomized controlled trial. Aging Ment Health. 2018 Oct;22(10):1351-1356. doi: 10.1080/13607863.2017.1348482. Epub 2017 Jul 10.

  PMID: 28691893 RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 2, 2014
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 22, 2025

Record last verified: 2017-02

Locations

FR (3)