CClinicalTrials.gg
Sign In
CompletedNCT00537992Updated Oct 2, 2007

Blue-Blocking IOLs in Combined Surgery

An interventional study of combined surgery in Epiretinal Membranes, Macular Holes and Cataract, sponsored by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2007-10-02.

Sponsored by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Epiretinal Membranes
  • Macular Holes
  • Cataract

Keywords

  • combined surgery,
  • cataract surgery,
  • vitrectomy,
  • blue light-filter iols
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pseudophakia on the non-study eye
  • The need for silicone oil tamponade
  • Optic atrophy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Interventions

  • Procedurecombined surgery

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

06

What researchers measure

Primary outcomes

  1. intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome

Secondary outcomes

  1. complication rates and vitreoretinal diagnoses

07

Study locations

No study locations are listed for this record.

08

References and documents

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 16597662 ↗
  • 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. PubMed 16023990 ↗
  • 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. PubMed 18191090 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00537992
Lead sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
First posted
Oct 2, 2007
Start date
Oct 2004
Completion
Mar 2006
Last update
Oct 2, 2007

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cataract→

Other studies from this sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Start the discussion