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OpenTrials
Completed

NCT Number: NCT00537992

Blue-Blocking IOLs in Combined Surgery

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.

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Key information

Conditions

Epiretinal Membranes Cataract Epiretinal Membrane Eye Diseases Lens Diseases Macular Holes Retinal Diseases Retinal Perforations

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

combined surgery

Procedure

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

Primary outcomes

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

Secondary outcomes

  1. complication rates and vitreoretinal diagnoses

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Registry information

Official study title

Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.

Important dates

Study start
2004
Study completion
2006
First posted
Oct 2, 2007
Registry last updated
Oct 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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