Clarifying the Optimal Application of SLT Therapy Trial

Conditions

• Glaucoma and Ocular Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Low Energy SLT — PROCEDURE
  SLT performed at low energy
• Standard Energy SLT — PROCEDURE
  SLT performed at standard energy

Study Details

The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.

Key Dates

Start date

Sep 7, 2021

Status verified

Sep 2025

Primary completion

Jun 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

790 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Trial 1: Initial standard energy SLT
  Standard energy SLT is performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots.
• Experimental: Trial 2: Month 12 Randomization: Annual Low Energy Repeat SLT
  At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy. Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ is no bubbles are seen with 5 consecutive spots.
• Active Comparator: Trial 2: Month 12 Randomization: As-Needed Repeat SLT at Standard Energy
  At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy. Standard SLT will be performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots.
• Experimental: Trial 1: Initial Low Energy SLT
  Note: This arm was discontinued following a planned interim analysis. Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ if no bubbles are seen with 5 consecutive spots.

Primary Outcome Measure

12-month survival [ Time Frame: 12 months ]

Central Contacts

• Tony Realini, MD, MPH
  3045986926
  [email protected]

Locations (28)

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