Randomized trial of radial optic neurotomy, triamcinolone for CRVO started in Europe
NUREMBERG, Germany — A multicenter clinical study of two treatments for central retinal vein occlusion has been initiated in Europe, a speaker here said.
The trial, which is to enroll 240 patients at 22 centers in Europe and elsewhere, will compare the use of radial optic neurotomy and intravitreal triamcinolone injection for the treatment of central retinal vein occlusion, said Susanne Binder, MD. Speaking here at the Congress of German Ophthalmic Surgeons, she described the trial as the first multinational effort to compare the efficacy of the two treatments.
“Radial optic neurotomy and triamcinolone are used frequently and often in an uncontrolled fashion in small studies [to treat CRVO],” Dr. Binder said. “We need a randomized trial.”
The study will include 240 patients followed for 12 months. The primary endpoint, she said, will be best corrected visual acuity at 1 year after treatment. The participants’ vascular changes will also be studied.
One group of patients in the trial will be given a 4 mg dose of intravitreal triamcinolone, Dr. Binder said, and another will undergo radial optic neurotomy.
Patients with central vein occlusion who are included in the study will have nonperfusion of more than 10 disc diameters.
Dr. Binder said a similar single-center study of 30 patients at her university in Vienna is looking at choroidal blood flow preoperatively and postoperatively, as well as retrobulbar blood flow velocity and IOP.
“The pathogenesis of venous occlusion is still the subject of controversial discussion,” Dr. Binder said. “It will be the end of the study that will demonstrate to what extent we can achieve our goal with radial optic neurotomy.”