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The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study

NCT04758598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-17

No results posted yet for this study

Summary

The objective of this study is to compare the long-term (6 months) effects of Direct Selective Laser Trabeculoplasty (DSLT) treatment and SLT (Selective Laser Trabeculoplasty) treatment on corneal endothelial cell counts and corneal thickness.

Conditions

Interventions

DEVICE

Direct Selective Laser Trabeculoplasty (DSLT)

DSLT employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus.

DEVICE

Selective Laser Trabeculoplasty (SLT)

SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area).

Sponsors & Collaborators

  • BelkinVision

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-04-15
Completion
2022-05-06

Countries

  • Georgia

Study Locations

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Entities

Diseases

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 NCT04758598 on ClinicalTrials.gov