Laser Treatments for Glaucoma

Overseen By Recruitment Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Brimonidine, Apraclonidine

Disqualifiers: Advanced POAG, Other glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

51 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment DSLT, SLT for glaucoma?

Research shows that Selective Laser Trabeculoplasty (SLT) effectively lowers eye pressure in patients with open-angle glaucoma, which is crucial for managing the condition. SLT is as effective as previous laser treatments and eye drops, with the added benefits of being repeatable and not requiring patient adherence to medication. ^{1 2 3 4 5}

Is laser treatment for glaucoma safe?

Selective laser trabeculoplasty (SLT) is generally considered safe for treating glaucoma. It has mild and temporary side effects like inflammation and eye pain, with a small risk of moderate pressure increases in the eye after the procedure. Serious complications are rare. ^{6 7 8 9 10}

How do DSLT and SLT treatments for glaucoma differ from other treatments?

DSLT and SLT are laser treatments for glaucoma that target specific cells in the eye to lower eye pressure without damaging surrounding tissue. Unlike other laser treatments, they use very short laser pulses to avoid spreading heat, making them safer and potentially more effective. ^{1 4 11 12 13}

What is the purpose of this trial?

This study compares two laser treatments for open-angle glaucoma: Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT). SLT is a widely used procedure that requires a manual technique with a goniolens, while DSLT is a new, automated, non-contact method using the Eagle system. The study will evaluate whether DSLT is as effective as SLT in reducing intraocular pressure (IOP). Participants will be randomly assigned to receive either treatment and will be monitored over 12 months to assess changes in IOP, medication use, and safety outcomes. The goal is to determine if the simpler DSLT procedure can provide similar results to SLT, potentially improving patient comfort and access to glaucoma care.

Research Team

Jella An, MD, MBA

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for individuals with open-angle glaucoma, including pigmentary glaucoma. Participants should not have other types of glaucoma and must be suitable candidates for laser eye treatments.

Inclusion Criteria

Gonioscopically visible scleral spur for 360 degrees

Ability to provide informed consent

I have been diagnosed with open-angle glaucoma or high eye pressure.

Exclusion Criteria

Mean intraocular pressure >35 mmHg at screening or baseline visit in either eye

I have narrow or closed angles in my eye.

Pregnancy or plan to become pregnant in the next 1 year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either DSLT or SLT treatment to reduce intraocular pressure

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits to assess IOP and medication use

Treatment Details

Interventions

• DSLT
• SLT

Trial Overview The study compares two laser treatments: the established Selective Laser Trabeculoplasty (SLT) and a new automated Direct SLT (DSLT) using the Eagle system. It aims to see if DSLT can match SLT in lowering eye pressure over a year.

Participant Groups

Group I: Arm 2- Selective Laser Trabeculoplasty (SLT) Experimental Treatment 1 Intervention

SLT is a widely used and effective laser therapy to lower intraocular pressure that requires operator expertise and carries risks of mild inflammation, corneal damage and discomfort. This is a standard laser system that requires the use of a gonioscopy lens placed on the cornea to administer.

Group II: Arm 1- DSLT (Direct Selective Laser Trabeculoplasty) Experimental Treatment 1 Intervention

DSLT is a well-established non-contact laser application that does not require a gonioscopy lens, reducing the risk of corneal damage and inflammation.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

Selective laser trabeculoplasty (SLT) effectively reduces intraocular pressure (IOP) in patients with primary open angle glaucoma and ocular hypertension, achieving a mean IOP reduction of 3.4 mm Hg (15%) at 3 months, 3.0 mm Hg (12.9%) at 12 months, and 2.7 mm Hg (12.1%) at 24 months.

SLT is a safe, non-thermal treatment option that can be used as a first-line therapy or for patients who do not respond to medication, although further long-term studies are needed to understand the sustained effects and biological mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term results after selective laser trabeculoplasty -- a clinical study on 269 eyes]. Best, UP., Domack, H., Schmidt, V.[2009]

Selective laser trabeculoplasty (SLT) effectively reduced intraocular pressure (IOP) by an average of 17.2% over two years in a study of 36 eyes from 26 patients, indicating its potential as a treatment for glaucoma.

While SLT decreased the need for glaucoma medications slightly, it does not completely replace topical treatments, suggesting that patient selection for SLT could be improved to enhance its cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Two-year outcomes of selective laser trabeculoplasty in open-angle glaucoma and ocular hypertension]. Zaninetti, M., Ravinet, E.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Long-term results after selective laser trabeculoplasty -- a clinical study on 269 eyes]. [2009]

2. India pubmed.ncbi.nlm.nih.gov

Repeat Selective Laser Trabeculoplasty for Glaucoma Patients: A Systematic Review and Meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty as a first-line therapy: a review. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

[Pressure reduction after selective laser trabeculoplasty with two different laser systems and after argon laser trabeculoplasty--a controlled prospective clinical trial on 284 eyes]. [2013]

5. Australia pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty: A review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse effects and short-term results after selective laser trabeculoplasty. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Selective Laser Trabeculoplasty: A Clinical Review. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The Glaucoma Laser Trial (GLT): 3. Design and methods. Glaucoma Laser Trial Research Group. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty: a review. [2008]

10. Germany pubmed.ncbi.nlm.nih.gov

[Status of Selective Laser Trabeculoplasty (SLT)]. [2019]

11. France pubmed.ncbi.nlm.nih.gov

[Two-year outcomes of selective laser trabeculoplasty in open-angle glaucoma and ocular hypertension]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty as adjunctive treatment for open-angle glaucoma vs following incisional glaucoma surgery in Chinese eyes. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). [2023]