A Phase 3 interventional study of Low Energy SLT and Standard Energy SLT in Glaucoma and Ocular Hypertension, sponsored by University of Pittsburgh. Recruiting at 29 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Pittsburgh · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 790 is above the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Standard Energy 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.
Procedure: Low Energy SLT
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.
Procedure: Standard 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.
Procedure: Low Energy SLT
SLT performed at low energy
SLT performed at standard energy
12-month survival
Survival of first SLT through Month 12
Time frame: 12 months
48-month survival
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
Time frame: 48 months
Mean IOP
Mean IOP at month 12
Time frame: 12 months
Long-term mean IOP
Mean IOP at each study visit
Time frame: 12, 24, 36, and 48 months
Incidence of IOP spikes
IOP spikes \> 5 mmHg on day of SLT
Time frame: 0, 12, 24, 36, and 48 months
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Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: At study completion
Access criteria: See above
Started Sep 2021 (actual). Primary completion is estimated for Jun 2027, 69 months after the start.
Of 33 phase 3 interventional studies under Glaucoma, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 69 months is above that.
How these figures are worked out, and which studies are left out of them.
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