Glaucoma and Ocular Hypertension study: Low Energy SLT vs Standard Energy SLT
Official title Clarifying the Optimal Application of SLT Therapy Trial
ClinicalTrials.gov ID: NCT04967989
What this study is testing
- What it's testing
- This study aims to find out if using a lower power setting for laser eye treatment is just as effective as the standard setting. It also checks if doing the treatment once a year helps avoid the need for daily eye drops better than waiting until the effect wears off.
- Who it's for
- People who have glaucoma or high pressure in the eye.
- What's involved
- Participants will receive laser eye treatment (SLT) at either a low or standard energy level. They will be monitored to see how well the treatment controls their eye pressure and whether they still need eye drops.
- Time commitment
- The study involves regular visits to check eye pressure and determine if the laser treatment needs to be repeated.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 or older and in good health
- High-risk ocular hypertension (OHT): IOP \> 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the...
- Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 dB with no points in the central 5°...
- Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 dB but no worse than...
- Each eye with BCVA 20/200 (UK 6/60) or better
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Age 18 or older and in good health
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Laguna Hills, California, United States
- Pasadena, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Sheridan, Colorado, United States
- Lakeworth, Florida, United States
- Chicago, Illinois, United States
- Orland Park, Illinois, United States
- Peoria, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Reading, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- The Bronx, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Kingston, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Laguna Hills, California, United States; Pasadena, California, United States; Sacramento, California, United States; San Francisco, California, United States; Sheridan, Colorado, United States; Lakeworth, Florida, United States and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.