New Horizons in the Treatment of Vitreous Floaters

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2016
The Ultra Q Reflex® (Ellex) constitutes the only Nd:YAG laser approved for the treatment of vitreous floaters. No randomized controlled clinical trial has been carried out to this day in order to investigate its superiority over sham treatment. In the present study, 60 eyes will be randomized and blinded into 2 groups, one receiving up to two sessions of laser vitreolysis the other scheduled for two sessions of sham treatment. After a maximum of two (sham) treatment sessions (1 per month), patients\' utility value score and BCVA will be re-assessed. A follow-up period of 12 months (with visits at month 1, 6 and 12 post-treatment) will ensue the \"treatment phase\" to register any late adverse events that may be associated with laser vitreolysis. As vitrectomy constitutes a highly invasive procedure, which must therefore be restricted to severe cases only, laser vitreolysis may present a valuable treatment option for patients with moderate vitreous floaters that are not eligible for vitrectomy.
Epistemonikos ID: c627c0379251aaf8f4896b5df9cb0aa0c361d8c5
First added on: May 17, 2024