Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The primary outcomes are to compare intraocular pressure control and glaucoma medication use up to 6 months after surgery."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares three devices used for goniotomy, a surgery to help fluid drain from the eye and lower eye pressure. It is for adults with open-angle glaucoma who are having cataract surgery and goniotomy together. The study will compare eye pressure and glaucoma medicine use for up to 6 months after surgery.
The goal of this study is to determine of one of three different devices to perform goniotomy to treat glaucoma at the time of cataract surgery is more or less effective than the others. The primary outcomes are to compare intraocular pressure control and glaucoma medication use up to 6 months after surgery. Participants will under combined cataract surgery and goniotomy. They will have post-operative follow up visits at 1 day, 1 week, 1 month, 3 months, and 6 month
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Have open-angle glaucoma, a disease that damages the eye’s main nerve even though the drainage angle is open.
- Scheduled for cataract surgery to remove a cloudy eye lens, with goniotomy planned at the same time.
- Able to understand the study and agree to take part.
Who can't join
- Have angle-closure glaucoma, in which the eye’s drainage angle is blocked.
- Have had glaucoma surgery in the eye being studied.
- Plan to have goniotomy without cataract surgery.
- Cannot attend follow-up visits at 1 day, 1 week, 1 month, 3 months, and 6 months after surgery.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Adults ≥ 18 years old * Diagnosed with primary or secondary open-angle glaucoma (e.g., POAG, pigmentary, pseudoexfoliative) * Scheduled for phacoemulsification with planned goniotomy * Able to provide informed consent Exclusion Criteria: * Angle-closure glaucoma * Prior glaucoma surgery in the study eye * Planned stand-alone goniotomy * Inability to comply with follow-up schedule
Study sites (1)
MI
- Henry Ford Health · Detroit, MI 48202David A Crandall, MD · Study contact · 248-661-5100 · dcranda1@hfhs.orgCalvin Robbins, MD · Study contact · 313-916-3260 · crobbin5@hfhs.orgNauman Imami, MD · Sub-investigatorPaul Baciu, MD · Sub-investigatorMore trials in Detroit