Clarifying the Optimal Application of SLT Therapy Trial

Not Applicable

Recruiting

• Conditions: Glaucoma and Ocular Hypertension

• 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

Study Timeline

• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-20
• Study Start: 2021-09-07
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-18
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 790

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Mean IOP	12 months	Mean IOP at month 12
Long-term mean IOP	12, 24, 36, and 48 months	Mean IOP at each study visit
Incidence of IOP spikes	0, 12, 24, 36, and 48 months	IOP spikes \> 5 mmHg on day of SLT

Trial Locations

Locations (29)

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

Mile High Eye Institute; 🇺🇸 Sheridan, Colorado, United States

Clear Vue Laser Eye Center; 🇺🇸 Lakeworth, Florida, United States

Northwestern Medical Group; 🇺🇸 Chicago, Illinois, United States

Chicago Arbor Eye Institute; 🇺🇸 Orland Park, Illinois, United States

Illinois Eye Center; 🇺🇸 Peoria, Illinois, United States

Wilmer Eye Institute Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

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