Clarifying the Optimal Application of SLT Therapy Trial
- Conditions
- Glaucoma and Ocular Hypertension
- Interventions
- Procedure: Low Energy SLTProcedure: Standard Energy SLT
- Registration Number
- NCT04967989
- Lead Sponsor
- University of Pittsburgh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 790
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description First Randomization: Low Energy SLT Low Energy SLT Low energy SLT will consist of 100 treatment spots delivered at 0.4mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3mJ 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. Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort. Second Randomization: Annual Low Energy Repeat SLT Low Energy SLT At month 12, subjects remaining medication-free will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above. First Randomization: Standard Energy SLT Standard Energy SLT 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. Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort. Second Randomization: As-Needed Repeat SLT at Initial Energy Low Energy SLT At month 12, subjects remaining medication-free will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above. Second Randomization: As-Needed Repeat SLT at Initial Energy Standard Energy SLT At month 12, subjects remaining medication-free will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above.
- Primary Outcome Measures
Name Time Method 12-month survival 12 months Survival of first SLT through Month 12
48-month survival 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 Outcome Measures
Name Time Method Long-term mean IOP 12, 24, 36, and 48 months Mean IOP at each study visit
Incidence of IOP spikes 0, 12, 24, 35, and 48 months IOP spikes \> 5 mmHg on day of SLT
Mean IOP 12 months Mean IOP at month 12
Trial Locations
- Locations (30)
Chicago Arbor Eye Institute
🇺🇸Orland Park, Illinois, United States
Harvard Eye Associates
🇺🇸Laguna Hills, California, United States
Doheny Eye Center UCLA
🇺🇸Pasadena, California, United States
University of California, Davis
🇺🇸Sacramento, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Illinois Eye Center
🇺🇸Peoria, Illinois, United States
Mile High Eye Institute
🇺🇸Sheridan, Colorado, United States
Clear Vue Laser Eye Center
🇺🇸Lakeworth, Florida, United States
Northwestern Medical Group
🇺🇸Chicago, Illinois, United States
Wilmer Eye Institute Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts Eye and Ear
🇺🇸Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Mark Latina, LLC
🇺🇸Reading, Massachusetts, United States
University of Michigan Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Kresge Eye Institute Wayne State University
🇺🇸Detroit, Michigan, United States
New York Eye Surgery Associates
🇺🇸Bronx, New York, United States
University Hospitals Eye Institute
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Devers Eye Institute
🇺🇸Portland, Oregon, United States
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Eye Center
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt Eye Institute
🇺🇸Nashville, Tennessee, United States
Ophthalmology Associates
🇺🇸Fort Worth, Texas, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
Ocular Health Centre
🇨🇦Kitchener, Ontario, Canada
Moorfields Eye Hospital
🇬🇧London, United Kingdom