Blue-Blocking IOLs in Combined Surgery

NCT ID: NCT00537992

Last Updated: 2007-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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

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Epiretinal Membranes Macular Holes Cataract

Keywords

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combined surgery, cataract surgery, vitrectomy, blue light-filter iols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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combined surgery

UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Pseudophakia on the non-study eye
* The need for silicone oil tamponade
* Optic atrophy.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role lead

Principal Investigators

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Susanne Binder, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Christiane I Falkner-Radler, MD

Role: STUDY_DIRECTOR

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

References

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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.

Reference Type BACKGROUND
PMID: 16597662 (View on PubMed)

Olson 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.

Reference Type BACKGROUND
PMID: 16023990 (View on PubMed)

Falkner-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.

Reference Type DERIVED
PMID: 18191090 (View on PubMed)

Other Identifiers

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FR-CI-03-2007

Identifier Type: -

Identifier Source: org_study_id