MedTrace Logo

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

NCT02304900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-22

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-12-31
Completion
2012-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304900 on ClinicalTrials.gov