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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.
Glaucoma management is fundamentally aimed at reducing intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Selective Laser Trabeculoplasty (SLT) has been a cornerstone in the treatment of open-angle glaucoma due to its efficacy and safety profile. However, SLT's manual delivery method using a goniolens can introduce variability, patient discomfort, and operator dependency.
Direct Selective Laser Trabeculoplasty (DSLT) represents an innovative advancement, offering a non-contact, automated laser treatment via the Eagle system. This technology is designed to simplify the procedure, enhance patient comfort, and minimize operator-induced variability. Early evidence suggests that DSLT may provide similar or improved IOP reduction compared to SLT, with a potentially better safety profile.
This study seeks to rigorously evaluate whether DSLT is non-inferior to SLT in reducing IOP, thus providing critical data on the efficacy and safety of this novel approach. Demonstrating non-inferiority would support broader adoption of DSLT, potentially improving patient outcomes and expanding access to effective glaucoma treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- DSLT (Direct Selective Laser Trabeculoplasty) | Other | DSLT is a well-established non-contact laser application that does not require a gonioscopy lens, reducing the risk of corneal damage and inflammation. |
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| Arm 2- Selective Laser Trabeculoplasty (SLT) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSLT treatment for Open-Angle Glaucoma | Device | This intervention aims to determine the efficacy and safety of Direct Selective Laser Trabeculoplasty (DSLT) in reducing intraocular pressure in patients with open-angle glaucoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Measuring the difference in the average IOP measurement reduction from the patient's baseline at 6 months between the DSLT and the SLT groups. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | The patients percentage of IOP reduction at 2 months, 6 months, and 12 months. Measuring the amount of patient's that have achieved >/= 20% IOP reduction at 6 months. Documentation of any change in the use of ocular hypotensive medications at 12 months. Documentation of the rate of repeat laser treatments or additional IOP lowering procedures. | 12 months |
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Inclusion Criteria:
Age ≥18 years.
Diagnosed with OAG (including exfoliative/pigmentary glaucoma) or OHT.
Gonioscopically visible scleral spur for 360 degrees.
Ability to provide informed consent.
In good health, without prior laser trabeculoplasty, with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both.
Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jella An, MD, MBA | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Health West Ophthalmology Clinic | Charleston | South Carolina | 29407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39976961 | Result | Konstantakopoulou E, Gazzard G, Garway-Heath D, Adeleke M, Ambler G, Vickerstaff V, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Selective Laser Trabeculoplasty After Medical Treatment for Glaucoma or Ocular Hypertension. JAMA Ophthalmol. 2025 Apr 1;143(4):295-302. doi: 10.1001/jamaophthalmol.2024.6492. | |
| 34003939 | Result |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| SLT treatment for Open-Angle Glaucoma | Device | To determine the efficacy and safety of using Selective Laser Trabeculoplasty for treatment of open-angle glaucoma. |
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| Goldenfeld M, Belkin M, Dobkin-Bekman M, Sacks Z, Blum Meirovitch S, Geffen N, Leshno A, Skaat A. Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial. Transl Vis Sci Technol. 2021 Mar 1;10(3):5. doi: 10.1167/tvst.10.3.5. |
| 32106630 | Result | Melik Parsadaniantz S, Reaux-le Goazigo A, Sapienza A, Habas C, Baudouin C. Glaucoma: A Degenerative Optic Neuropathy Related to Neuroinflammation? Cells. 2020 Feb 25;9(3):535. doi: 10.3390/cells9030535. |