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

Cataract Clinical Trial

— IOL et sommeil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304900
• Other study ID #: PHRI09-PJP / IOL et sommeil
• Status: Completed
• Phase: N/A
• First received: November 27, 2014
• Last updated: February 23, 2017
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2017
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• white implant
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
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

Locations

Country	Name	City	State
France	Service d'Ophtalmologie	Brest
France	Service d'Ophtalmologie, Centre Hospitalier Paul Martinais	Loches
France	Service d'Ophtalmologie	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation between before and 2 months after surgery sleep time		2 months
Secondary	Variation between before and 2 months after surgery the number of hours of sleep		2 months
Secondary	Variation between before and 2 months after surgery of the quality of sleep		2 months
Secondary	Variation between before and 2 months after surgery the mood evaluation score		2 months