Selective, Micropulse and Pattern Laser Trabeculoplasty in Medically Treated Open-angle Glaucoma.

NCT07756411 | Completed

• 1 other identifier: OCU_DMED_TRAB_2026_1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, single-centre, three-arm trial compared three subvisible laser trabeculoplasty delivery protocols in eyes with open-angle glaucoma already receiving intraocular pressure (IOP)-lowering medication: selective laser trabeculoplasty (SLT, 3-nanosecond pulses), micropulse laser trabeculoplasty (MLT, 577 nm with 15% duty cycle), and pattern laser trabeculoplasty (PLT, 5-ms pattern delivery). Ninety eyes of 90 patients were allocated 1:1:1 to a single 360-degree session and followed for 6 months. The primary outcome was IOP at 6 months, with an equivalence margin of +/-2.0 mmHg prespecified for pairwise comparisons. Secondary outcomes were percentage IOP change, number of IOP-lowering medications, cumulative treatment success (IOP reduction of at least 20% from baseline without an increase in medications), and adverse events. Outcome assessment was performed by a second ophthalmologist masked to allocation and to clinical history.

Conditions

Ocular Hypertension; Open-Angle Glaucoma

Keywords

laser trabeculoplasty; selective laser trabeculoplasty; micropulse laser trabeculoplasty; pattern laser trabeculoplasty; intraocular pressure; open-angle glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure at 6 months

  Intraocular pressure (mmHg) measured by Goldmann applanation tonometry at the same time of day (+/- 1 hour) by an assessor masked to allocation. At every visit three consecutive readings were taken and their arithmetic mean used in the analysis. The treatment effect was the adjusted mean difference in 6-month intraocular pressure between each pair of treatment groups, estimated by analysis of covariance with baseline intraocular pressure as a covariate; a difference of +/-2.0 mmHg was prespecified as the equivalence margin.

  6 months after treatment

Secondary Outcomes (4)

• Percentage change in intraocular pressure from baseline

  1 day, 1 week, 1 month, 3 months and 6 months after treatment

• Number of intraocular pressure-lowering medications

  1 week, 1 month, 3 months and 6 months after treatment

• Cumulative treatment success

  from month 1 through 6 months after treatment

• Adverse events, including postoperative intraocular pressure spike

  from treatment through 6 months

Study Arms (3)

Selective laser trabeculoplasty (SLT)

ACTIVE COMPARATOR

Single 360-degree session of selective laser trabeculoplasty with 3-nanosecond pulses, approximately 100 non-overlapping 400-micrometre spots, pulse energy titrated to visible microbubble formation in approximately 50% of applications up to a maximum of 1.4 mJ per pulse.

Device: Selective laser trabeculoplasty

Micropulse laser trabeculoplasty (MLT)

EXPERIMENTAL

Single 360-degree session of micropulse laser trabeculoplasty at 577 nm, 1000 mW, 300-ms envelope, 300-micrometre spot, 15% duty cycle.

Device: Micropulse laser trabeculoplasty

Pattern laser trabeculoplasty (PLT)

EXPERIMENTAL

Single 360-degree session of pattern laser trabeculoplasty at 577 nm: power titrated with 10-ms pulses until light blanching of the meshwork, then exposure shortened to 5 ms, with 100-micrometre spots delivered in 32 automatically rotating arc-shaped patterns of three rows of 13 spots, zero spacing, for approximately 1250 spots over 360 degrees.

Device: Pattern laser trabeculoplasty

Interventions

Selective laser trabeculoplasty DEVICE

Nanosecond-pulse laser trabeculoplasty delivered over 360 degrees with a Tango laser (Ellex Medical Lasers, Adelaide, Australia) after two drops of pilocarpine 2% and topical anaesthetic.

Selective laser trabeculoplasty (SLT)

Pattern laser trabeculoplasty DEVICE

Short-exposure pattern laser trabeculoplasty delivered over 360 degrees with a Pascal Streamline 577 (Topcon, Tokyo, Japan) after two drops of pilocarpine 2% and topical anaesthetic.

Pattern laser trabeculoplasty (PLT)

Micropulse laser trabeculoplasty DEVICE

Micropulsed 577-nm laser trabeculoplasty delivered over 360 degrees with an IQ 577 laser (Iridex, Mountain View, California, USA) after two drops of pilocarpine 2% and topical anaesthetic.

Micropulse laser trabeculoplasty (MLT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults with primary or secondary open-angle glaucoma.
• gonioscopically open angle confirmed by gonioscopy in the study eye.
• receiving intraocular pressure-lowering medication at entry, with an indication for subvisible laser trabeculoplasty according to standard practice at the unit (IOP inadequately controlled on medical therapy, intolerance of medical therapy, or both).
• written informed consent.

You may not qualify if:

• previous laser trabeculoplasty, iridotomy or iridoplasty.
• corneal disease precluding visualization of the trabecular meshwork or reliable applanation tonometry.
• previous intraocular surgery other than uncomplicated cataract extraction.
• systemic medication known to affect intraocular pressure.
• pregnancy.

Sponsors & Collaborators

• University of Udine: lead

Study Sites (1)

Glaucoma Unit, Department of Medicine - Ophthalmology, University of Udine

Udine, UD, 33100, Italy

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Daniele Veritti

  Department of Ophthalmology, University of Udine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and the treating surgeon were not masked to allocation, which is not feasible when the three lasers differ in console and audible signature. All intraocular pressure measurements and anterior segment examinations were performed by a second ophthalmologist masked to allocation and to clinical history. Medication changes were decided by the unmasked treating physician, so masking did not extend to the co-intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: February 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)