A Study to Assess an Automated Laser Device for Direct Selective Laser Trabeculoplasty

NCT03750201 | Completed

• 1 other identifier: GLAUrious-2017-01
• Study Type: interventional
• Target: 201
• Locations: 3 countries
• Sites: 8

Brief Summary

Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition. Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of fluid from inside the eye. This has the potential of reducing the intraocular pressure within the eye (the main way in which this disease is treated since there is no cure) and may assist in helping to control the progression of this disease. SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is conducted using a special type of lens (goniolens) that gently sits on the front surface of the eye. The procedure takes approximately 5 minutes in duration. This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly, without there being any need to use a goniolens which sits on the eye, and it is a shorter and simpler technique to conduct when compared to the standard SLT technique. The purpose of this study is to assess the hypothesis that the treatment by new automated device for DSLT is not worse in comparison with the standard SLT and determine that it is effective in reducing intraocular pressure.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment

  The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment

  6 months

Secondary Outcomes (2)

• Number of medications as compare to screening visit

  6 months

• Proportion of subjects with at least 20% reduction in IOP from baseline

  6 months

Other Outcomes (1)

• Incidence of adverse events

  12 months

Study Arms (2)

Direct Selective Trabeculoplasty

EXPERIMENTAL

Treatment by the investigational device.

Device: Direct Selective Trabeculoplasty

Selective Trabeculoplasty

ACTIVE COMPARATOR

Treatment by the comparator device.

Device: Selective Trabeculoplasty

Interventions

Direct Selective Trabeculoplasty DEVICE

Laser surgery by automated direct automated SLT device to lower intraocular pressure

Direct Selective Trabeculoplasty

Selective Trabeculoplasty DEVICE

Laser surgery by standard SLT device to lower intraocular pressure

Selective Trabeculoplasty

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 years or older, with visual acuity \> 6/60 in both eyes
• Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension
• IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications)
• Gonioscopically visible scleral spur for 360 degrees without indentation
• Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
• Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule
• Participant capable of giving informed consent

You may not qualify if:

• Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc.)
• Angle Closure Glaucoma
• Congenital or developmental glaucoma
• Secondary glaucoma except exfoliative or pigmentary glaucoma
• Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
• Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
• Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:
• A visual field MD of worse than -12dB
• Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
• At least 50% of points (i.e 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
• Points within the central 5 degrees of fixation with a sensitivity \<15 dB in both hemifields on the decibel plot
• A visual field MD of worse than -12dB in the fellow eye
• Cup:Disc Ratio of more than 0.8
• More than three hypotensive mediations required
• Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye

Sponsors & Collaborators

• BelkinVision: lead
• European Commission: collaborator
• Universita degli Studi di Genova: collaborator
• Queen's University, Belfast: collaborator
• Moorfields Eye Hospital NHS Foundation Trust: collaborator

Study Sites (8)

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Universita degli Studi di Genova

Genova, Italy

Location

Queens University Belfast

Belfast, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Related Publications (2)

• Gazzard G, Congdon N, Azuara-Blanco A, Blumenthal EZ, Gomelauri K, Zaliniyan M, Traverso CE, Bracha Z, Dvalishvili A, Solberg Y, Belkin M, Samuelson TW; GLAUrious Study Group. Randomized Noninferiority Trial of Direct Selective Laser Trabeculoplasty in Open-Angle Glaucoma and Ocular Hypertension: GLAUrious Study. Ophthalmology. 2025 Oct;132(10):1091-1104. doi: 10.1016/j.ophtha.2025.05.004. Epub 2025 May 9.

  PMID: 40350086 BACKGROUND

• Congdon N, Azuara-Blanco A, Solberg Y, Traverso CE, Iester M, Cutolo CA, Bagnis A, Aung T, Fudemberg SJ, Lindstrom R, Samuelson T, Singh K, Blumenthal EZ, Gazzard G; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023 Jan;107(1):62-65. doi: 10.1136/bjophthalmol-2021-319379. Epub 2021 Aug 25.

  PMID: 34433548 DERIVED

Related Links

• Link to the manuscript in Ophthalmology

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Nathan Congdon, MD, MPH

  Queens University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Intra-ocular pressure (IOP) measurements by masked investigator or masked technique (masked reading).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: October 19, 2018
• Primary Completion: April 15, 2022
• Study Completion: May 22, 2022
• Last Updated: July 24, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); IL (5); GB (2)