Blue-Blocking IOLs in Combined Surgery
Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.
1 other identifier
interventional
60
0 countries
N/A
Brief 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 procedures and on the patients' outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 2, 2007
CompletedOctober 2, 2007
October 1, 2007
October 1, 2007
October 1, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome
Secondary Outcomes (1)
complication rates and vitreoretinal diagnoses
Interventions
UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pseudophakia on the non-study eye
- The need for silicone oil tamponade
- Optic atrophy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 16597662BACKGROUNDOlson 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.
PMID: 16023990BACKGROUNDFalkner-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.
PMID: 18191090DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne Binder, Prof., MD
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
- STUDY DIRECTOR
Christiane I Falkner-Radler, MD
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 2, 2007
Study Start
October 1, 2004
Study Completion
March 1, 2006
Last Updated
October 2, 2007
Record last verified: 2007-10