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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02304900

Acronym

IOL et sommeil

Enrollment

400

Registered

2014-12-02

Start date

2009-12-31

Completion date

2012-12-31

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

cataract

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.

Interventions

OTHERwhite 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

OTHERyellow implant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Variation between before and 2 months after surgery sleep time	2 months

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026