Clarifying the Optimal Application of SLT Therapy Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
- Enrollment
- 790
- Locations
- 58
- Primary Endpoint
- 12-month survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel assignment
- Primary Purpose
- Treatment
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 18 or older and in good health
- Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
- High-risk ocular hypertension (OHT): IOP > 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of >0.2 between eyes)
- Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 dB with no points in the central 5° <15 dB (see figure on next page)
- Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5° points <15 dB or mean deviation -12.0 dB or better with 1 central 5° points <15 dB (see figure on next page).
- Each eye with BCVA 20/200 (UK 6/60) or better
Exclusion Criteria
- Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years (this is a modification implemented during active enrollment)
- Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure
- Advanced POAG in either eye (worse than moderate POAG as defined above)
- Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
- Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
- Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
- Contraindications to SLT or any other study intervention
- Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
- Any intraocular surgical procedure within the past 6 months in either eye
- Inability to attend all scheduled study visits
- Pregnant or planning to become pregnant in the next 4 years
Arms & Interventions
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.
Intervention: Low Energy SLT (Procedure)
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.
Intervention: Standard Energy SLT (Procedure)
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.
Intervention: Standard Energy SLT (Procedure)
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.
Intervention: Low Energy SLT (Procedure)
Outcomes
Primary Outcomes
12-month survival
Time Frame: 12 months
Survival of first SLT through Month 12
48-month survival
Time Frame: 48 months
At Month 12, subjects are randomized to repeat SLT either annually at low energy or PRN at standard energy. The proportion controlled with SLT alone at Month 48 will be compared between groups
Secondary Outcomes
- Mean IOP(12 months)
- Long-term mean IOP(12, 24, 36, and 48 months)
- Incidence of IOP spikes(0, 12, 24, 36, and 48 months)
Investigators
Balasubramani Goundappa
Research Associate Professor
University of Pittsburgh
Study Sites (58)
Identifiers
- NCT ID
- NCT04967989
- Other Study IDs
- STUDY21060171, 2UG1EY031651-06, UG1EY031651, STUDY21080018
Dates
- First Submitted
- (5 years ago)
- First Posted
- (5 years ago)
- Primary Completion
- (in 9 months)
- Study Completion
- (in 11 months)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- Yes
- Has Results
- No
All study data will be de-identified. We will invite other investigators to submit secondary data requests using the data from the study and will work with those investigators to foster additional research studies and manuscripts. The investigators agree to abide by the principles for sharing research resources as described by "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources." All publications based on the study will adhere to the NIH Public Access Policy (Notice NOT-OD-08-033). At the end of the study, all study data will be submitted for permanent archive per the notice of grant award.