Excimer Laser Trabeculostomy Glaucoma Treatment Study
Not Applicable
Active, not recruiting
- Conditions
- Glaucoma, Primary Open Angle
- Registration Number
- NCT04899063
- Lead Sponsor
- Elios Vision, Inc.
- Brief Summary
Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG) undergoing cataract surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 318
Inclusion Criteria
- Diagnosis of mild to moderate POAG
- Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse
- Medicated IOP of <=24 mmHg
- Unmedicated diurnal IOP of >=22 mmHg and <=34 mmHg
- Shaffer angle grade of III or IV
- CD ratio <=0.8
- At least 45 years old
Exclusion Criteria
- Closed-angle and secondary glaucomas
- Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
- Cannot undergo medication washout in the study eye
- Diagnosis of degenerative visual disorders
- Non-study eye with BCVA worse than 20/80
- Known corticosteroid responder
- Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% 24 Month Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
- Secondary Outcome Measures
Name Time Method Mean Change in medication-free DIOP from baseline 24 Month Mean change in medication-free DIOP from baseline
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the ELIOS System's intraocular pressure reduction in primary open-angle glaucoma?
How does the ELIOS Procedure compare to trabeculectomy and MIGS in IOP control and complication rates for POAG patients?
Which ocular biomarkers correlate with successful trabeculostomy outcomes using the ELIOS System in cataract surgery?
What are the potential adverse events associated with excimer laser trabeculostomy and their management strategies?
Are there combination therapies involving the ELIOS System and prostaglandin analogs for POAG treatment optimization?
Trial Locations
- Locations (2)
ELIOS Vision Clinical Site
🇺🇸Kenosha, Wisconsin, United States
Elios Vision Clinical Site 2
🇺🇸San Antonio, Texas, United States
ELIOS Vision Clinical Site🇺🇸Kenosha, Wisconsin, United States