Macular DegenerationBluMelNCT00444249
Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin
A study testing White Alcon IOL, Yellow Alcon IOL and White Hoya IOL in people with Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
The "blue light hazard" has been reported to cause retinal damage (oxidative stress), particularly to the central fovea due to its energetic, shorter wavelength visible photons, which is why blue-light filtering intraocular lenses have been developed for cataract surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- White Alcon IOL, Yellow Alcon IOL and White Hoya IOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2007to Aug 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are included if they meet all of the following inclusion criteria:
- Cataract on one or both eyes
- Study eye with non-exudative AMD AREDS I - III
- Men or women aged between 60 - 99 years
- Patient planned for cataract surgery and in need of an intraocular lens
Who cannot join
- Patients are excluded if they meet one or more of the following exclusion criteria:
- Study eye with exudative AMD
- Study eye with concomitant retinal or choroidal disorder other than AMD
- Study eye with significant keratopathies
- Fundus not visible
- Intake of medication known to affect melatonin secretion (within the last 12 hours): ß-blockers, calcium channel blockers, a-blockers, non-steroidal anti-inflammatory drugs, benzodiazepines, antidepressants, hypnotic drugs, antipsychotics, barbiturates, antiepileptic drugs, and melatonin
- Alcohol or caffeine consumption 6 hours before vein puncture
- Patients who are unwilling to adhere to visit examination schedules
Trial locations and contacts
1 site in 1 country.
Austria1 site
Rudolf Foundation Clinic, Department of Ophthalmology
Vienna, State of Vienna, 1030
About this study
Official title: Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration
The "blue light hazard" has been reported to cause retinal damage (oxidative stress), particularly to the central fovea due to its energetic, shorter wavelength visible photons, which is why blue-light filtering intraocular lenses have been developed for cataract surgery. The hormone melatonin has been reported to possess an efficient antioxidant capacity. Light information from the eye reaches the suprachiasmatic nuclei and inhibits melatonin secretion. Since melatonin is suppressed by light, we have a day-night rhythmicity, with increased levels at night. Melatonin suppression is wavelength-dependent with a peak sensitivity in the 446-477 nm (blue light) portion of the visible spectrum. The crystalline lens blocks most UV between 300 and 400 nm. The density of the lens increases with aging causing an alteration in the spectral absorption. The greatest increase in absorption occurs at the short wavelength end of the spectrum (around 400-470 nm). Age-related pupillary miosis and crystalline lens yellowing limit the blue light reaching the retina. This reduces the older adults' effective retinal light exposure to one tenth that of younger people. It has been shown that insomnia and depression decrease after cataract surgery and patients returned to youthful levels of melatonin. Since melatonin acts as an antioxidant, and more blue light filtering intra ocular lenses are implanted and thought to reduce photochemical damage in the macula, it would be interesting to show the positive influence of those blue light filtering intraocular lenses on daytime levels of melatonin in age-related macular degeneration patients.
Read the detailed description
Patients with non-exudative age-related macular degeneration, which are planned for cataract surgery, will be randomized into one of four groups. Group I and II are blue light filtering intraocular lenses and group III and IV are white lenses. Group I and III are lenses form Alcon, group II and IV are lenses form Hoya. The following examinations will be performed before, 1 month, 6 months, 1 year and 2 years after surgery: vein puncture for melatonin analysis, visual acuity, complete slit lamp analysis including intraocular pressure, pupil size measurement, and questionnaire about sleeping time and sleeping quality. At the follow-up visits the following examinations will also be performed: autofluorescein imaging, infrared imaging, and optical coherence tomography imaging. Vein puncture will be performed between 8 and 10 a.m. and has to be performed at the same time for the same patient. Pupils are not allowed to be dilated by the time of vein puncture and pupil size measurement.
- Conditions
- Macular Degeneration
- Being tested
- White Alcon IOL, Yellow Alcon IOL, White Hoya IOL, Yellow Hoya IOL
- Keywords
- age-related macular degeneration, melatonin, blue-light filter
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Alcon IOLProcedure or surgery
Implantation of white Alcon IOL
Yellow Alcon IOLProcedure or surgery
Implantation of yellow Alcon IOL
White Hoya IOLProcedure or surgery
Implantation of white Hoya IOL
Yellow Hoya IOLProcedure or surgery
Implantation of yellow Hoya IOL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | White Alcon IOL Receives: Procedure: White Alcon IOL |
| 2 | Active comparator | Yellow Alcon IOL Receives: Procedure: Yellow Alcon IOL |
| 3 | Active comparator | White Hoya IOL Receives: Procedure: White Hoya IOL |
| 4 | Active comparator | Yellow Hoya IOL Receives: Procedure: Yellow Hoya IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin daytime levels in serum
Measured: 1, 6, 12, and 36 months postoperative
Secondary outcomes (1)
Number of drusen, retinal thickness, pupil size, sleeping time
Measured: 1, 6, 12, and 36 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Because only a few patients follow the inclusion and exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Katharina E. Schmid-Kubista, MD, Principal investigator, LBI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444249
- Sponsor's protocol ID
- LBI-06-172-1006
- Acronym
- BluMel
- Status last verified
- Apr 2009
- First submitted
- 5 Mar 2007
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00444249
- Acronym / sponsor ID
- BluMel / LBI-06-172-1006
- Conditions
- Macular Degeneration
- Keywords
- age-related macular degeneration, melatonin, blue-light filter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because only a few patients follow the inclusion and exclusion criteria.
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Mar 2007 (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 "blue light hazard" has been reported to cause retinal damage (oxidative stress), particularly to the central fovea due to its energetic, shorter wavelength visible photons, which is why blue-light filtering intraocular lenses have been developed for cataract surgery. The hormone melatonin has been reported to possess an efficient antioxidant capacity. Light information from the eye reaches the suprachiasmatic nuclei and inhibits melatonin secretion. Since melatonin is suppressed by light, we have a day-night rhythmicity, with increased levels at night. Melatonin suppression is wavelength-dependent with a peak sensitivity in the 446-477 nm (blue light) portion of the visible spectrum. The crystalline lens blocks most UV between 300 and 400 nm. The density of the lens increases with aging causing an alteration in the spectral absorption. The greatest increase in absorption occurs at the short wavelength end of the spectrum (around 400-470 nm). Age-related pupillary miosis and crystalline lens yellowing limit the blue light reaching the retina. This reduces the older adults' effective retinal light exposure to one tenth that of younger people. It has been shown that insomnia and depression decrease after cataract surgery and patients returned to youthful levels of melatonin. Since melatonin acts as an antioxidant, and more blue light filtering intra ocular lenses are implanted and thought to reduce photochemical damage in the macula, it would be interesting to show the positive influence of those blue light filtering intraocular lenses on daytime levels of melatonin in age-related macular degeneration patients.
Detailed description
Patients with non-exudative age-related macular degeneration, which are planned for cataract surgery, will be randomized into one of four groups. Group I and II are blue light filtering intraocular lenses and group III and IV are white lenses. Group I and III are lenses form Alcon, group II and IV are lenses form Hoya. The following examinations will be performed before, 1 month, 6 months, 1 year and 2 years after surgery: vein puncture for melatonin analysis, visual acuity, complete slit lamp analysis including intraocular pressure, pupil size measurement, and questionnaire about sleeping time and sleeping quality. At the follow-up visits the following examinations will also be performed: autofluorescein imaging, infrared imaging, and optical coherence tomography imaging. Vein puncture will be performed between 8 and 10 a.m. and has to be performed at the same time for the same patient. Pupils are not allowed to be dilated by the time of vein puncture and pupil size measurement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: White Alcon IOLWhite Alcon IOL |
| 2 | Active comparator | Procedure: Yellow Alcon IOLYellow Alcon IOL |
| 3 | Active comparator | Procedure: White Hoya IOLWhite Hoya IOL |
| 4 | Active comparator | Procedure: Yellow Hoya IOLYellow Hoya IOL |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cataract on one or both eyes
- Study eye with non-exudative AMD AREDS I - III
- Men or women aged between 60 - 99 years
- Patient planned for cataract surgery and in need of an intraocular lens
Key exclusion criteria (8 listed)
- Study eye with exudative AMD
- Study eye with concomitant retinal or choroidal disorder other than AMD
- Study eye with significant keratopathies
- Fundus not visible
- Intake of medication known to affect melatonin secretion (within the last 12 hours): ß-blockers, calcium channel blockers, a-blockers, non-steroidal anti-inflammatory drugs, benzodiazepines, antidepressants, hypnotic drugs, antipsychotics, barbiturates, antiepileptic drugs, and melatonin
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 Alcon IOLImplantation of white Alcon IOL | Procedure or surgery | 1 |
| Yellow Alcon IOLImplantation of yellow Alcon IOL | Procedure or surgery | 2 |
| White Hoya IOLImplantation of white Hoya IOL | Procedure or surgery | 3 |
| Yellow Hoya IOLImplantation of yellow Hoya IOL | Procedure or surgery | 4 |
Primary outcome
Melatonin daytime levels in serum
Time frame: 1, 6, 12, and 36 months postoperative
1 secondary outcome
Number of drusen, retinal thickness, pupil size, sleeping time
Time frame: 1, 6, 12, and 36 months postoperative
Results and safety
The study was stopped early (reason given: Because only a few patients follow the inclusion and exclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
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.
Katharina E. Schmid-Kubista, MD principal investigator
LBI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Alcon IOL, Yellow Alcon IOL and White Hoya IOL in people with Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Apr 2009. 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 Austria. 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 was stopped early (reason given: Because only a few patients follow the inclusion and exclusion criteria.). Results are not available in the source record.
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?
Melatonin daytime levels in serum (time frame: 1, 6, 12, and 36 months postoperative). 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 22 Apr 2009.