Direct Selective Laser Trabeculoplasty for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new laser treatment for individuals with high eye pressure or open-angle glaucoma, a condition that can lead to vision loss. The treatment, Direct Selective Laser Trabeculoplasty (DSLT), uses a laser that does not touch the eye, potentially making it faster and more comfortable. Researchers aim to determine if it safely lowers eye pressure in those who have already tried another laser treatment. Ideal candidates for this trial have open-angle glaucoma or high eye pressure and have previously undergone a laser treatment called SLT. Participants will temporarily stop using glaucoma eye drops to assess how well the new treatment works independently.
As an unphased trial, this study provides a unique opportunity to explore a potentially more comfortable treatment option for managing eye pressure.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop your usual glaucoma eye drops for a short time before your eye pressure is measured. This helps show the true effect of the laser treatment.
What prior data suggests that this laser treatment is safe for glaucoma patients?
Research has shown that Direct Selective Laser Trabeculoplasty (DSLT) is generally well-tolerated by people with glaucoma. Studies have found that over half of the patients who received DSLT stopped using medication after one year. Importantly, these studies did not report any major side effects. Additionally, DSLT matches the effectiveness of the traditional laser treatment, Selective Laser Trabeculoplasty (SLT), in lowering eye pressure, which is essential for managing glaucoma.
Furthermore, comparisons between DSLT and SLT have demonstrated similar safety levels. The FDA has approved the device used in DSLT, confirming it meets safety standards for medical devices. This approval indicates a proven safety record for treating eye conditions like those in this study.12345Why are researchers excited about this trial?
Direct Selective Laser Trabeculoplasty (DSLT) is unique because it offers a non-invasive approach to lowering intraocular pressure in glaucoma patients. Unlike traditional treatments like medicated eye drops or surgery, DSLT uses a laser to target the trabecular meshwork in the eye, potentially improving fluid drainage and reducing eye pressure. Researchers are excited about DSLT because it could provide a more precise and controlled method of treatment with fewer side effects, and it does not rely on medications that can be difficult for patients to use consistently.
What evidence suggests that Direct Selective Laser Trabeculoplasty is effective for glaucoma?
Research has shown that Direct Selective Laser Trabeculoplasty (DSLT), the treatment under study in this trial, effectively lowers eye pressure in people with open-angle glaucoma. One study reported a 25–30% reduction in eye pressure, aiding in glaucoma management. Another study found an average decrease of about 3.2 mmHg, comparable to traditional laser treatments like SLT. DSLT has also reduced the need for glaucoma medications in many patients. Although some studies suggest DSLT isn't always superior to SLT, it still provides a significant and lasting reduction in eye pressure, making it a promising option for treating glaucoma.12567
Who Is on the Research Team?
Nathan Radcliffe, M.D.
Principal Investigator
New York Eye Surgery Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who have high eye pressure or open-angle glaucoma, and have already had a laser treatment called SLT. Participants must be able to stop their glaucoma medications before the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Washout
Participants undergo a washout period to stop glaucoma medications before baseline IOP assessment
Treatment
Participants receive Direct Selective Laser Trabeculoplasty (DSLT) in one eye
Follow-up
Participants are monitored for safety and effectiveness after treatment, with IOP assessments at 1, 3, and 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Direct Selective Laser Trabeculoplasty (DSLT)
Trial Overview
The study tests Direct Selective Laser Trabeculoplasty (DSLT), a non-contact laser procedure, in people with glaucoma or high eye pressure who previously had SLT. All participants receive DSLT to see how well it lowers eye pressure over six months.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants undergo direct selective laser trabeculoplasty (DSLT) in one eye using a fixed-energy protocol (120 shots, 400 µm spot size, 1.8 mJ, no titration). Intraocular pressure (IOP) is assessed at baseline (following medication washout) and during follow-up visits at 1 month, 3 months, and 6 months. A medication washout is required prior to baseline and the 6-month assessment. IOP-lowering medications may be introduced during follow-up based on investigator-defined thresholds.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The New York Eye Surgery Center
Lead Sponsor
Citations
Real World Comparison of Direct Selective Laser ... - PMC
The primary outcome measures were mean absolute and percent IOP reduction, number of medications, and BCVA at 1, 3, 6, and 12 months. ... Results: ...
First results of direct selective laser trabeculoplasty for the ...
Data from this study suggest DSLT to be a safe and effective IOP-lowering procedure both in primary open-angle glaucoma (POAG) and in primary ...
Randomized Noninferiority Trial of Direct Selective Laser ...
The GLAUrious study failed to demonstrate that DSLT was noninferior to SLT. However, DSLT did provide effective IOP reduction for 12 months in patients with ...
Direct Selective Laser Trabeculoplasty
The Laser in Glaucoma and Ocular Hypertension (LIGHT) trial demonstrated that SLT, when performed as primary therapy, was effective 75% of the time, ...
5.
ophthalmologyadvisor.com
ophthalmologyadvisor.com/news/direct-selective-laser-trabeculoplasty-at-6-months-falls-short-of-non-inferiority/Direct Selective Laser Trabeculoplasty At 6 Months Falls ...
At 12 months, of 161 eyes, 77 with SLT displayed a 3.2 (±0.4) mm Hg reduction. Similarly, 84 having DSLT also lessened by 3.2 (±0.4) mm Hg (P <.
Unlock First-Line Glaucoma Care with Voyager™ DSLT
Indications: Voyager™ DSLT is indicated for use in selective laser trabeculoplasty (SLT). Contraindications: Use of the Voyager™ DSLT device is contraindicated ...
Direct Selective Laser Trabeculoplasty (DSLT) for Patients ...
Direct Selective Laser Trabeculoplasty (DSLT) for Patients With Glaucoma or Ocular Hypertension Previously Treated With SLT · Study Overview.
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