CataractNCT00710996
Blue Light Intraocular Lenses (IOLs) and Photostress
An observational study of Cataract, run by Alcon Research at 1 site in United States.
Trial summary
To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Oct 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with existing bilateral Intraocular Lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.
Who may be able to join
- Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery.
Who cannot join
- Age related
Trial locations and contacts
1 site in 1 country.
United States1 site
Call Alcon Call Center for Study Locations
Fort Worth, Texas, 76134
About this study
To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.
- Conditions
- Cataract
- Keywords
- AcrySof IQ IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AcrySof Natural Intraocular Lens | AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN" | |
| AcrySof clear intraocular lens | AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA" | |
| Phakic patients | Phakic patients - Age matched patients who have not had cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photostress Recovery Time in Seconds.
The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Alcon ResearchThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710996
- Sponsor's protocol ID
- M07-023
- Status last verified
- Jan 2010
- First submitted
- 3 Jul 2008
- Last updated
- 2 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hammond BR, Bernstein B, Dong J. The Effect of the AcrySof natural lens on glare disability and photostress. Am J Ophthalmol. 2009 Aug;148(2):272-276.e2. doi: 10.1016/j.ajo.2009.03.014. Epub 2009 May 7.
PubMed 19426959
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Light Intraocular Lenses (IOLs) and Photostress
- ClinicalTrials.gov ID
- NCT00710996
- Acronym / sponsor ID
- M07-023
- Conditions
- Cataract
- Keywords
- AcrySof IQ IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 29 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AcrySof Natural Intraocular Lens | – | –AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN" |
| AcrySof clear intraocular lens | – | –AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA" |
| Phakic patients | – | –Phakic patients - Age matched patients who have not had cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with existing bilateral Intraocular Lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.
Key inclusion criteria (1 listed)
- Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery.
Key exclusion criteria (1 listed)
- Age related
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Photostress Recovery Time in Seconds.
Time frame: 3 months
The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19426959Hammond BR, Bernstein B, Dong J. The Effect of the AcrySof natural lens on glare disability and photostress. Am J Ophthalmol. 2009 Aug;148(2):272-276.e2. doi: 10.1016/j.ajo.2009.03.014. Epub 2009 May 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Alcon Research at 1 site in United States.
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 1 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 2 Feb 2010. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Photostress Recovery Time in Seconds. (time frame: 3 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 NCT00710996, 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 2 Feb 2010.