Clarifying the Optimal Application of SLT Therapy Trial

Launched by UNIVERSITY OF PITTSBURGH · Jul 19, 2021

Keywords

ClinConnect Summary

The Clarifying the Optimal Application of SLT Therapy Trial is a study aimed at understanding whether using a lower energy level during a specific eye treatment called Selective Laser Trabeculoplasty (SLT) is as effective as the standard energy level. SLT is often used to help manage conditions like glaucoma and ocular hypertension, which can cause increased pressure in the eyes. This study will also look at whether receiving this treatment once a year at low energy can help reduce the need for daily eye drop medications better than waiting for the effects of the first treatment to wear off before doing it again.

To be eligible for this trial, participants need to be at least 18 years old and generally healthy, with specific eye conditions such as mild to moderate primary open-angle glaucoma or high-risk ocular hypertension. Participants will need to attend multiple study visits, where they will receive the treatment and undergo assessments to monitor their eye health. This study is currently recruiting individuals of all genders, so if you or someone you know is interested and meets the criteria, it could be a great opportunity to contribute to important research in eye care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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)
• • 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:
• • 1. 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)
• • 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