NCT04758598

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: BelkinVision · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rational: SLT has known transient effect on corneal endothelial cell (CEC) counts yet no data is yet available with DSLT. This study is relevant as the DSLT treatment area is at the limbus: CEC progenitor site

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-04-15
• Completion: 2022-05-06
• First posted: 2021-02-17
• Last updated: 2023-01-17

Locations

1 site across 1 country: Georgia