Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05902871 |
Other study ID # |
#China-2022-01 (CA-PL-01-008) |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 15, 2023 |
Est. completion date |
December 24, 2024 |
Study information
Verified date |
June 2023 |
Source |
BelkinVision |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to evaluate the safety and effectiveness of Direct Selective
Laser Trabeculoplasty (DSLT) at various energy settings in ethnic Chinese participants with
POAG or OHT.
Description:
Geffen et al investigated the safety & effectiveness of performing trans-scleral/limbal SLT
without the use of a gonioscopic lens. They were able to show that this technique was as
efficacious as conventional SLT, taking less time as well as causing fewer complications due
to its non-contact methodology and with the laser beam not passing diagonally through the
cornea. The study comprised of 14 control subjects, and 14 treated subjects; all with primary
open-angle glaucoma. The controls were treated using traditional SLT for 360 degrees, using a
goniolens to direct the laser beams. The treatment group received the same laser treatment,
but this was administered directly to the peri-limbal area. Success (a decrease of ≥15% at 6
months with no additional medications, laser, or glaucoma surgery) was achieved in 12 (85.7%)
study patients and 9 (69.2%) controls (p = 0.385). Complications were mild and transient in
both groups, although significantly more common within the control group (p< 0.0001).
First-in Human open-label, prospective study was performed in Sheba Medical Center, Israel
(cliniclatrials.gov NCT01383525, accepted for publication) with the aim to assess safety and
efficacy of the EAGLE system on IOP reduction in POAG patients (manuscript submitted for
publication). 15 subjects were enrolled and treated. The results show good safety profile and
an IOP reduction of 18.1%, 21.4%, 18.8% at 1, 3 and 6 months follow- up visits respectively.
The number of medications was also reduced. 14 subjects were medicated at baseline with an
average of 1.6±1.0 medications per subject. At 6 months, only 3 subjects were medicated with
an average of 0.4±0.9 medications per subject.
A European multicenter randomized controlled masked study, the GLAUrious trial, was initiated
in October 2018. The objective of this study is to demonstrate the non-inferiority of the
novel DSLT compared to SLT. 192 subjects were enrolled. No ocular SAE were reported up to
date in the DSLT arm (cliniclatrials.gov NCT03750201) and results of the trial are expected
in a few months.
SLT is an approved treatment option available to OAG patients that can be used with or
without hypotensive lowering medication to reduce IOP. The safety and effectiveness of SLT
has been demonstrated. , , , Due to its IOP lowering effect, this treatment may result in a
decrease in the number of or elimination in the need for hypotensive lowering medications.
Inflammatory reactions following SLT include cystoid macular edema and anterior chamber
inflammation (more common). , , The inflammation is usually mild to moderate in its severity
and transient, with reductions in intensity seen within 24 hours post-treatment, and
resolution seen in most eyes within 5 days. Another risk associated with laser
trabeculoplasty treatment is the incidence of post-operative IOP spikes. These usually occur
in the immediate post-operative phase (1-2 hours) and careful patient selection and
prophylactic treatment can be used to avoid their occurrence.
DSLT is performed directly, and preliminary studies have demonstrated that it is a shorter
and simpler technique when compared to SLT4. Further, it has been suggested that it could be
more easily administered in those patients where contact techniques prove problematic or
where anatomical obstacles exist, such as in those patients with narrow iridocorneal angles
or those with prominent facial bones.4 This same study demonstrated similar IOP lowering
effectiveness between DSLT and SLT. Furthermore, it revealed that DSLT resulted in less
corneal injury, less inflammation and less post-operative discomfort when compared to
standard SLT.
Accordingly, risks of inclusion in the study are those associated with the SLT procedure.
Preliminary studies suggest that treatment with DSLT is comparable to SLT. Benefits of DSLT
include a speedier treatment, less post-operative inflammation, and less subjective
discomfort. In addition, this simple automatic procedure does not require use of a goniolens
and therefore has the potential to increase the accessibility of glaucoma care throughout the
world.
This clinical trial is a non-randomized, multi-center, prospective study. As the Eagle system
was not tested before in ethnic Chinese population. The objective of this study is to
evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) at
various energy settings in ethnic Chinese participants with POAG or OHT.