Vanderbilt Clinical Trials

Clarifying the Optimal Application of SLT Therapy Trial

Purpose

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.

Condition

Glaucoma and Ocular Hypertension

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Age 18 or older and in good health 2. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes): 1. 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) [enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment] 2. 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) 3. 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). 3. 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 2. Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure 3. Advanced POAG in either eye (worse than moderate POAG as defined above) 4. Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye 5. Mean IOP > 35 mmHg at either the screening or baseline visit in either eye 6. Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye 7. Contraindications to SLT or any other study intervention 8. Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye 9. Any intraocular surgical procedure within the past 6 months in either eye 10. Inability to attend all scheduled study visits 11. Pregnant or planning to become pregnant in the next 4 years

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are randomized twice: the first, at study entry, to low energy or standard SLT; and the second, at Month 12, to annual or as-needed repeat SLT. There are 2 arms in the first 12 months of the study and 2 different arms in Months 13-48.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental First Randomization: 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.	Procedure: Low Energy SLT SLT performed at low energy
Active Comparator First Randomization: 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.	Procedure: Standard Energy SLT SLT performed at standard energy
Experimental Second Randomization: Annual Low Energy Repeat 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.	Procedure: Low Energy SLT SLT performed at low energy
Active Comparator Second Randomization: As-Needed Repeat SLT at Initial Energy	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.	Procedure: Low Energy SLT SLT performed at low energy Procedure: Standard Energy SLT SLT performed at standard energy

Recruiting Locations

Vanderbilt Eye Institute
Nashville, Tennessee 37232

Contact:
Marybeth Carter
616-936-1639
marybeth.l.carter@vumc.org

More Details

Status: Recruiting
Sponsor: West Virginia University

Study Contact

Tony Realini, MD, MPH
3045986926
hypotonywvu@gmail.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.