CataractCIRCATNCT01686308
The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans
A study testing Yellow Intra Ocular Lens (IOL) and Conventional Intra Ocular Lens (IOL) in people with Cataract, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Cataract is globally the most common cause of blindness and in Denmark the operation with - 50.000 treatments per year - is the most common eye operation. The cause of cataract is growth and denaturation of the lens proteins. This leads to an increased absorption of blue light and increased light scatter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Yellow Intra Ocular Lens (IOL) and Conventional Intra Ocular Lens (IOL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age related/senile bilateral cataract
- Eligible for phaco-emulsification on both eyes
Who cannot join
- Known eye disease other than cataract.
- Known systemic disease, which may affect the retina (untreated hypertension, DM etc.)
- Known systemic disease, which may affect the lens.
- Known psychiatric disease.
- Known sleep or circadian rhythm disorder, not caused by lowered blue light transmission by the lens.
- Per- and post operative complications
Show all 15Show fewer
- Use of drugs that may affect the sleep.
- For a subpopulation also:
- Poor cooperation.
- Severe refraction abnormalities.
- Previous eye surgery
- Nystagmus
- Congenital or acquired abnormalities of: eye lids and eye area, cornea or iris.
- Use of medicine that may affect the pupillary response.
- Use of drugs that may affect the pupillary response.
Trial locations and contacts
1 site in 1 country.
About this study
Cataract is globally the most common cause of blindness and in Denmark the operation with - 50.000 treatments per year - is the most common eye operation. The cause of cataract is growth and denaturation of the lens proteins. This leads to an increased absorption of blue light and increased light scatter. This may affect newly discovered cells in the retina that are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is not synchronized with the external day and night a phase-shift occurs. Most people know of this discomfort as jet-lag, but the consequences may be much more severe such as heighten risk of cancer and cardiovascular disease.
The goal of this project is to study how the circadian regulating cells of the retina is affected by cataract and by the operation. Cataract patients are studied before and after the operation with questionnaires, hormone and activity measurements and with a specialized pupil measurement that measures the indirect response of the circadian regulating cells to blue light.
Results from this study aim to shed light on the regulatory mechanisms of the eye on the circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular lens is evaluated. This may have impact on clinical practise especially with regard to choice of intraocular lens and widened indications for cataract surgery.
- Conditions
- Cataract
- Being tested
- Yellow Intra Ocular Lens (IOL), Conventional Intra Ocular Lens (IOL)
- Keywords
- cataract, circadian rhythm, pupillometry, blue light transmission, questionnaire, sleep
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow Intra Ocular Lens (IOL)Procedure or surgery
Standard operation with blue light filter Yellow IOL implantation
Conventional Intra Ocular Lens (IOL)Procedure or surgery
Standard operation with conventional IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| Conventional Intra Ocular Lens (IOL) | Active comparator | Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation. Receives: Procedure: Conventional Intra Ocular Lens (IOL) |
| Yellow Intra Ocular Lens (IOL) | Experimental | Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation. Receives: Procedure: Yellow Intra Ocular Lens (IOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary response to blue light
Measurement of the consensual light response to red (630 nm) and blue (470 nm)
Measured: 1 year/1month
Secondary outcomes (4)
Questionnaire
Pittsburgh Sleep Quality Index and the Morningness Eveningness Questionnaire
Measured: 1year/1month
Questionnaire
Morningness-eveningness questionnaire
Measured: 1 year/1 month
Melatonin day variety analysis
Salivary samples collected with 4 hour interval during 24 hours. Analyzed for melatonin concentration with Radio Immuno Assay (RIA).
Measured: 1year/1month
Actigraphy
Activity measured during 7 days and 7 nights with the Spectrum Actiwatch, Respironics, Philips
Measured: 1year/1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Elias Brøndsted, Glostrup University Hospital, Copenhagen
- Investigators
- Adam E Brøndsted, MD, Principal investigator, Glostrup UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686308
- Sponsor's protocol ID
- CIRCAT
- Acronym
- CIRCAT
- Status last verified
- Feb 2015
- First submitted
- 30 Nov 2011
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans
- ClinicalTrials.gov ID
- NCT01686308
- Acronym / sponsor ID
- CIRCAT / CIRCAT
- Conditions
- Cataract
- Keywords
- cataract, circadian rhythm, pupillometry, blue light transmission, questionnaire, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Sep 2012 (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.
Cataract is globally the most common cause of blindness and in Denmark the operation with - 50.000 treatments per year - is the most common eye operation. The cause of cataract is growth and denaturation of the lens proteins. This leads to an increased absorption of blue light and increased light scatter. This may affect newly discovered cells in the retina that are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is not synchronized with the external day and night a phase-shift occurs. Most people know of this discomfort as jet-lag, but the consequences may be much more severe such as heighten risk of cancer and cardiovascular disease.
The goal of this project is to study how the circadian regulating cells of the retina is affected by cataract and by the operation. Cataract patients are studied before and after the operation with questionnaires, hormone and activity measurements and with a specialized pupil measurement that measures the indirect response of the circadian regulating cells to blue light.
Results from this study aim to shed light on the regulatory mechanisms of the eye on the circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular lens is evaluated. This may have impact on clinical practise especially with regard to choice of intraocular lens and widened indications for cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Intra Ocular Lens (IOL) | Active comparator | Procedure: Conventional Intra Ocular Lens (IOL)Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation. |
| Yellow Intra Ocular Lens (IOL) | Experimental | Procedure: Yellow Intra Ocular Lens (IOL)Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age related/senile bilateral cataract
- Eligible for phaco-emulsification on both eyes
Key exclusion criteria (15 listed)
- Known eye disease other than cataract.
- Known systemic disease, which may affect the retina (untreated hypertension, DM etc.)
- Known systemic disease, which may affect the lens.
- Known psychiatric disease.
- Known sleep or circadian rhythm disorder, not caused by lowered blue light transmission by the lens.
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 |
|---|---|---|
| Yellow Intra Ocular Lens (IOL)Standard operation with blue light filter Yellow IOL implantation | Procedure or surgery | Yellow Intra Ocular Lens (IOL) |
| Conventional Intra Ocular Lens (IOL)Standard operation with conventional IOL implantation | Procedure or surgery | Conventional Intra Ocular Lens (IOL) |
Primary outcome
Pupillary response to blue light
Time frame: 1 year/1month
Measurement of the consensual light response to red (630 nm) and blue (470 nm)
4 secondary outcomes
Questionnaire
Time frame: 1year/1month
Questionnaire
Time frame: 1 year/1 month
Melatonin day variety analysis
Time frame: 1year/1month
Actigraphy
Time frame: 1year/1month
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 10 Feb 2015.
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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.
Adam E Brøndsted, MD principal investigator
Glostrup UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yellow Intra Ocular Lens (IOL) and Conventional Intra Ocular Lens (IOL) in people with Cataract, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 2 inclusion and 15 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Pupillary response to blue light (time frame: 1 year/1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2015.