Epiretinal MembranesNCT00537992
Blue-Blocking IOLs in Combined Surgery
A study testing combined surgery in people with Epiretinal Membranes and Macular Holes, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Trial summary
Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Epiretinal Membranes, Macular Holes, Cataract
- What is being tested?
- combined surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Mar 2006
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema)
- Coexisting significant cataract
- The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation)
- Age over 50 years.
Who cannot join
- Pseudophakia on the non-study eye
- The need for silicone oil tamponade
- Optic atrophy.
About this study
Official title: Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.
Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.
Read the detailed description
Sixty patients were randomly assigned to receive a UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure.
Outcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.
- Conditions
- Epiretinal Membranes, Macular Holes, Cataract
- Being tested
- combined surgery
- Keywords
- combined surgery,, cataract surgery,, vitrectomy,, blue light-filter iols
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined surgeryProcedure or surgery
UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome
Secondary outcomes (1)
complication rates and vitreoretinal diagnoses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startOct 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembranesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Binder, Prof., MD, Principal investigator, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser SurgeryChristiane I Falkner-Radler, MD, Study director, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537992
- Sponsor's protocol ID
- FR-CI-03-2007
- Status last verified
- Oct 2007
- First submitted
- 1 Oct 2007
- Last updated
- 2 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayashi K, Hayashi H. Visual function in patients with yellow tinted intraocular lenses compared with vision in patients with non-tinted intraocular lenses. Br J Ophthalmol. 2006 Aug;90(8):1019-23. doi: 10.1136/bjo.2006.090712. Epub 2006 Apr 5.
PubMed 16597662Olson RJ, Werner L, Mamalis N, Cionni R. New intraocular lens technology. Am J Ophthalmol. 2005 Oct;140(4):709-16. doi: 10.1016/j.ajo.2005.03.061. Epub 2005 Jul 18.
PubMed 16023990Falkner-Radler CI, Benesch T, Binder S. Blue light-filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. Am J Ophthalmol. 2008 Mar;145(3):499-503. doi: 10.1016/j.ajo.2007.10.021. Epub 2008 Jan 11.
PubMed 18191090
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT00537992
- Acronym / sponsor ID
- FR-CI-03-2007
- Conditions
- Epiretinal Membranes, Macular Holes, Cataract
- Keywords
- combined surgery,, cataract surgery,, vitrectomy,, blue light-filter iols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 2 Oct 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.
Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.
Detailed description
Sixty patients were randomly assigned to receive a UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure.
Outcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema)
- Coexisting significant cataract
- The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation)
- Age over 50 years.
Key exclusion criteria (3 listed)
- Pseudophakia on the non-study eye
- The need for silicone oil tamponade
- Optic atrophy.
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 |
|---|---|---|
| combined surgeryUV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure | Procedure or surgery | – |
Primary outcome
intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome
1 secondary outcome
complication rates and vitreoretinal diagnoses
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 2 Oct 2007.
- Background: PubMed 16597662Hayashi K, Hayashi H. Visual function in patients with yellow tinted intraocular lenses compared with vision in patients with non-tinted intraocular lenses. Br J Ophthalmol. 2006 Aug;90(8):1019-23. doi: 10.1136/bjo.2006.090712. Epub 2006 Apr 5.
- Background: PubMed 16023990Olson RJ, Werner L, Mamalis N, Cionni R. New intraocular lens technology. Am J Ophthalmol. 2005 Oct;140(4):709-16. doi: 10.1016/j.ajo.2005.03.061. Epub 2005 Jul 18.
- Derived from this study: PubMed 18191090Falkner-Radler CI, Benesch T, Binder S. Blue light-filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. Am J Ophthalmol. 2008 Mar;145(3):499-503. doi: 10.1016/j.ajo.2007.10.021. Epub 2008 Jan 11.
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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.
Susanne Binder, Prof., MD principal investigator
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Christiane I Falkner-Radler, MD study director
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Questions about this trial
What is this clinical trial studying?
A study testing combined surgery in people with Epiretinal Membranes and Macular Holes, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
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 3 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 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome. 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 NCT00537992, which also lists 3 linked publications.
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 Oct 2007.