Clinical trial for Glaucoma
Official title Glaucoma Laser Assessment of Stability and Sustainability
ClinicalTrials.gov ID: NCT06963684
What this study is testing
- What it's testing
- The study aims to find out if getting the laser treatment twice works better than once at keeping eye pressure low without daily drops.
- Who it's for
- People with early-stage glaucoma or high eye pressure.
- What's involved
- Participants will receive laser treatment in both eyes. After three months, one eye will get a second treatment while the other serves as a comparison.
- Time commitment
- The study lasts one year and involves follow-up visits to check safety and eye pressure.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Male and female patients aged 40 years or older
- A bilateral diagnosis of ocular hypertension, glaucoma suspect, or mild primary open angle glaucoma as defined by AAO PPP
- Treatment naïve with an unmedicated IOP between 21-35 mmHg, inclusive, and within +/- 3mmHg of each eye to be eligible
- BCVA of 20/50 or better
- The subject is able to read and understand the requirements of the study and provide written informed consent.
You likely can't join if
- Unable to view scleral spur inferiorly with gonioscopy.
- Congenital or developmental glaucoma, angle closure glaucoma, secondary glaucoma (e.g.
- Use of oral or ocular hypotensive medication for glaucoma.
- Prior history of ocular surgery except for cataract surgery (must be ≥ 2 years prior)
- Clinically significant ocular pathology, other than cataract and glaucoma, including but not limited to neovascular age-related macular degeneration...
- Clinically significant ocular inflammation or infection within 6 months prior to screening.
See the full eligibility criteria
- Male and female patients aged 40 years or older
- A bilateral diagnosis of ocular hypertension, glaucoma suspect, or mild primary open angle glaucoma as defined by AAO PPP
- Treatment naïve with an unmedicated IOP between 21-35 mmHg, inclusive, and within +/- 3mmHg of each eye to be eligible
- BCVA of 20/50 or better
- The subject is able to read and understand the requirements of the study and provide written informed consent.
- The subject is willing to follow study instructions, agrees to comply with all study procedures and attend all scheduled follow-up exams for 12 months after the initial treatment.
- Unable to view scleral spur inferiorly with gonioscopy.
- Congenital or developmental glaucoma, angle closure glaucoma, secondary glaucoma (e.g. exfoliative, pigmentary, etc.) pigmentary, neovascular glaucoma, closed angle glaucoma, or uveitic glaucoma.
- Use of oral or ocular hypotensive medication for glaucoma.
- Prior history of ocular surgery except for cataract surgery (must be ≥ 2 years prior)
- Clinically significant ocular pathology, other than cataract and glaucoma, including but not limited to neovascular age-related macular degeneration, advanced dry macular degeneration, and proliferative diabetic...
- Clinically significant ocular inflammation or infection within 6 months prior to screening.
- Previous corneal transplant or clinically significant corneal dystrophy, e.g., Fuch's dystrophy (≥12 confluent guttae)
- Unclear ocular media prevent visualization of the fundus or anterior chamber angle.
- Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's health at risk and/or prevent the subject from completing all study visits.
- Current participation in another investigational drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days.
- Cataract surgery (if ≥ 2 years or screening)
- YAG capsulotomy (if ≥ 60 days of screening)
The study team makes the final eligibility decision.
Where it is enrolling
- Coon Rapids, Minnesota, United States
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Coon Rapids, Minnesota, United States. 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.