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

NCT ID: NCT02304900

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Cataract

Keywords

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cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

white implant

Intervention Type 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

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

Group Type EXPERIMENTAL

yellow implant

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service d'Ophtalmologie

Brest, , France

Site Status

Service d'Ophtalmologie, Centre Hospitalier Paul Martinais

Loches, , France

Site Status

Service d'Ophtalmologie

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 28691893 (View on PubMed)

Other Identifiers

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PHRI09-PJP / IOL et sommeil

Identifier Type: -

Identifier Source: org_study_id