Clinical Data

Proof of Concept

Status: Completed 2014

Number of Patients: 28

Primary Endpoint: IOP reduction at 6 months

The proof of concept of our technology was successfully achieved by a randomized controlled trial (RCT) performed in Israel, published in the Journal of Glaucoma.

Two groups of 14 patients each were treated: the control group was treated with the traditional SLT, delivering 100 laser beams manually to the treatment area through a gonioscopy lens.

The study group was treated with the traditional SLT device, but implementing BELKIN’s external method, delivering 100 laser beams to the trabecular meshwork through the sclera without lens. We achieved the same effectiveness with less side effects.

The results clearly showed that after one year of follow-up there was no difference in IOP reduction between the conventional approach and BELKIN’s innovative approach. With respect to side-effects and patient discomfort, the external BELKIN application was superior to the conventional method.

According to the ophthalmic literature, SLT treatment achieves a reduction in IOP of about 20% for 1 to 5 years in 80% of patients. In the POC clinical trial, a reduction of 23.7% was achieved after 3 months of follow up in 80% of patients.

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First-in-Human

Status: Completed 2019

Number of Patients: 15

Primary Endpoint: IOP reduction at 3 months

The First-in-Human trial was conducted as a non-randomized, single arm, and observer masked. Direct selective laser trabeculoplasty (DSLT) is a rapid, noncontact automated procedure performed directly through the limbus without gonioscopy. We assessed its safety and ability to reduce intraocular pressure (IOP).

Results showed that DSLT with the Eagle Clinical Automated device is effective in reducing IOP at 3M with 21%, and at 6M with 22% reduction at lower energies and 27% at the higher energy. There were no safety concerns. 79% of patients were drop-free at 6M.

Conclusions: Automated DSLT appears to be an effective and safe noncontact, rapid modality for reducing IOP in patients with OAG. Higher energy usage led to better results.

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GLAUrious – Multicenter Randomized Controlled Study

Status: Enrollment Complete

Number of Patients: 192

Primary Endpoint: IOP reduction at 6 months

This study is our pivotal multicenter randomized controlled study to assess the non-inferiority of the DSLT compared to SLT. The study is supported by a grant from the European commission (Horizon 2020 program).

There were two participating sites in the UK, one in Italy, 8 in Israel and 3 in the Republic of Georgia.

6-month follow up for primary endpoint is expected in January of 2022 and 12-month follow up is expected in Q3 of 2022.

View clinicaltrials.gov
View GLAUrious website
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