AVISI TECHNOLOGIES ANNOUNCES 12-MONTH CLINICAL DATA OF VISIPLATE AQUOUS SHUNT

Written By Michele Washko

Read the full press release here.

The VITA Trial, a prospective pilot study designed to assess the safety and efficacy of Avisi Technologies' VisiPlate® device, was conducted at three centers by three implanting surgeons in South Africa and treated 15 patients. All patients were diagnosed with Open Angle Glaucoma (OAG) and had no prior history of filtration surgery. The surgery was a unilateral implantation via an ab externo standalone procedure.

Result Highlights

  • Mean baseline diurnal IOP was 24.1 ± 6.2 mmHg; baseline glaucoma medications were 2.0 ± 1.5. Baseline Visual Field mean deviation was -11.7 ± 8.6 dB.

  • At 12 months, mean diurnal IOP was reduced to 13.1 ± 2.6 mmHg on 1.3 ± 1.5 medications, a change in diurnal IOP of –42.6% from baseline.

  • 46.7% of subjects were on no glaucoma medication at 12 months.

  • No serious adverse events were reported and no patients had persistent vision loss.

Michele Washko
Next

Berks Biomedical Innovation Collaborative Hosts Inaugural Conference