A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction
Not Applicable
Completed
- Conditions
- Open Angle Glaucoma
- Registration Number
- NCT02784249
- Lead Sponsor
- New World Medical, Inc.
- Brief Summary
The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
Inclusion Criteria
- Diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma)
- Diagnosis of mild to moderate glaucoma as defined by ICD-9 staging definitions 365.71 Mild/365.72 Moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma)
- Planned removal of a visually significant cataract as determined by the Investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction
Exclusion Criteria
- Any glaucoma diagnosis other than those noted in inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent reduction in mean IOP 12 months
- Secondary Outcome Measures
Name Time Method
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 efficacy of goniotomy versus trabecular micro-bypass stents in open-angle glaucoma?
How does ab interno goniotomy compare to trabecular bypass devices in reducing intraocular pressure post-cataract surgery?
Are there specific biomarkers that predict better outcomes for goniotomy or trabecular stent procedures in mild to moderate glaucoma patients?
What are the potential adverse events associated with novel goniotomy techniques in combined cataract-glaucoma surgeries?
How do ab interno glaucoma procedures compare to traditional trabeculectomy in terms of long-term efficacy and safety profiles?
Trial Locations
- Locations (1)
Gundersen Health System
🇺🇸La Crosse, Wisconsin, United States
Gundersen Health System🇺🇸La Crosse, Wisconsin, United States