A study to assess an automated device to treat glaucoma
Research type
Research Study
Full title
Direct Selective Laser Trabeculoplasty (DSLT) in Open Angle Glaucoma (OAG): A randomized controlled Trial
IRAS ID
227509
Contact name
Masha Dobkin-Bekman
Contact email
Sponsor organisation
BELKIN Laser
ISRCTN Number
ISRCTN14033075
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Summary of Research
The purpose of this study is to assess the safety and effectiveness of a new automated laser treatment for the treatment of glaucoma (Direct selective laser trabeculoplasty - DSLT), and to compare this to the standard laser treatment currently available worldwide (Selective Laser Trabeculoplasty - SLT) and to make sure that this new treatment is not inferior in reducing intraocular pressure.Summary of Results
This study demonstrated that DSLT with the Eagle device is effective in providing a clinically
meaningful reduction in IOP at 6 months that is sustained out to 12 months. While statistical
non-inferiority of DSLT compared with SLT was not conclusively demonstrated at 6 months for
the primary endpoint (i.e., mean change in IOP), non-inferiority was established at 12 months
for this key IOP outcome. In addition, non-inferiority was also established at 12 months for the
GLAUrious Study - Clinical Study Report (CSR)
CA-RP-01-006, Revision 01
CONFIDENTIAL
BELKIN Vision Ltd. Page 14 of 250
other key effectiveness outcomes of the success rate and a reduction in medication usage. For
a chronic disease like glaucoma, duration of effectiveness is important, so the fact that noninferiority
versus SLT was established at 12 months is an important clinical finding supporting
the benefit-risk profile of DSLT. The safety profile for both groups was similar, although more
punctate subconjunctival hemorrhage was observed in the DSLT group. The adverse events
that occurred during the study were typically mild and resolved without intervention. On the
basis of these results, it can be concluded that DSLT, performed with the Eagle device, is safe
and effective in reducing IOP in patients with OAG and ocular hypertension, and that the
benefits of DSLT outweigh its risks. Further, DSLT is posed to serve an immense and growing
clinical need in glaucoma care for greater availability of SLT due to the emergence of laser
trabeculoplasty as a first-line treatment, given the major limitations of topical medical therapy
and due to the large increase in the patient population.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
17/NW/0358
Date of REC Opinion
26 Jun 2017
REC opinion
Further Information Favourable Opinion