CataractIOL et sommeilNCT02304900
Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
A study testing white implant and yellow implant in people with Cataract, run by University Hospital, Tours at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- white implant and yellow implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female or male subject
- subject between 60 and 90 years old
- Visual acuteness < or = with 2 eyes
- Indication operating of the cataract
Who cannot join
- NA
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service d'Ophtalmologie
Brest
Service d'Ophtalmologie, Centre Hospitalier Paul Martinais
Loches, 37600
Service d'Ophtalmologie
Tours, 37
About this study
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
- Being tested
- white implant, yellow implant
- Keywords
- cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white implantOther
- 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 implantOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: yellow implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation between before and 2 months after surgery sleep time
Measured: 2 months
Secondary outcomes (3)
Variation between before and 2 months after surgery the number of hours of sleep
Measured: 2 months
Variation between before and 2 months after surgery of the quality of sleep
Measured: 2 months
Variation between before and 2 months after surgery the mood evaluation score
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304900
- Sponsor's protocol ID
- PHRI09-PJP / IOL et sommeil
- Acronym
- IOL et sommeil
- Status last verified
- Feb 2017
- First submitted
- 27 Nov 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28691893
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
- ClinicalTrials.gov ID
- NCT02304900
- Acronym / sponsor ID
- IOL et sommeil / PHRI09-PJP / IOL et sommeil
- Conditions
- Cataract
- Keywords
- cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : white implant | Experimental | Other: white implantRandomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know. |
| Group 2 : yellow implant | Experimental | Other: yellow implantRandomization will determine the color of the implant to be used for each patient for interventions in both eyes, white or yellow to know. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female or male subject
- subject between 60 and 90 years old
- Visual acuteness < or = with 2 eyes
- Indication operating of the cataract
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| white implant1. 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 | Group 1 : white implant |
| yellow implant1. 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 | Group 2 : yellow implant |
Primary outcome
Variation between before and 2 months after surgery sleep time
Time frame: 2 months
3 secondary outcomes
Variation between before and 2 months after surgery the number of hours of sleep
Time frame: 2 months
Variation between before and 2 months after surgery of the quality of sleep
Time frame: 2 months
Variation between before and 2 months after surgery the mood evaluation score
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 28691893Zambrowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing white implant and yellow implant in people with Cataract, run by University Hospital, Tours at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation between before and 2 months after surgery sleep time (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.