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

NCT03750201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-07-24

No results posted yet for this study

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

Interventions

DEVICE

Direct Selective Trabeculoplasty

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

DEVICE

Selective Trabeculoplasty

Laser surgery by standard SLT device to lower intraocular pressure

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Universita degli Studi di Genova

    collaborator OTHER

  • Queen's University, Belfast

    collaborator OTHER

  • Moorfields Eye Hospital NHS Foundation Trust

    collaborator OTHER

  • BelkinVision

    lead INDUSTRY

Principal Investigators

  • Nathan Congdon, MD, MPH · Queens University Belfast

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-19
Primary Completion
2022-04-15
Completion
2022-05-22

Countries

  • Israel
  • Italy
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750201 on ClinicalTrials.gov