Actively Recruiting
Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery
Led by Vold Vision P.L.L.C · Updated on 2024-08-13
25
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
V
Vold Vision P.L.L.C
Lead Sponsor
A
Alcon Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery. Patients will also undergo a minimally invasive type of glaucoma surgery using a special type of stent to reduce eye pressure, with the goal of better glaucoma control and the reduction in the need for medications to control eye pressure.
CONDITIONS
Official Title
Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 45 years of age or older
- Presence of visually significant age-related cataract in both eyes
- Diagnosis of mild open-angle glaucoma with visual field mean deviation not worse than -6.00 dB and/or nerve abnormalities consistent with glaucoma
- Medicated intraocular pressure at or below 25 mmHg on 1 to 3 hypotensive medications
- Glaucoma judged as stable by investigator with stable visual field and nerve fiber layer for at least 1 year and stable intraocular pressure on current medication for at least 3 months
- Shaffer grade of 3 or higher in all angle quadrants
- Potential for best corrected visual acuity at distance of at least 0.1 logMAR (20/25) postoperatively
- Able and willing to comply with follow-up visits
- Understands and signs informed consent
- Both eyes to undergo surgery within 21 days of each other
You will not qualify if you...
- Previous incisional glaucoma surgery or cilio-ablative surgery
- Prior laser trabeculoplasty within 90 days of surgery
- Diagnosis of pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma
- Moderate glaucoma with visual field mean deviation between -6.00 dB and -12.00 dB
- Severe or progressive glaucoma defined by visual field mean deviation worse than -12.00 dB, consistent worsening of visual field, progressive nerve fiber layer thinning, uncontrolled intraocular pressure on maximum medications, history of poor pressure control, severe optic nerve rim notching, or expectation for future incisional glaucoma surgery
- Ocular or medical conditions increasing risk of complications or significant vision loss during study
- Ocular pathologies impacting visual acuity postoperatively such as significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, or history of significant ocular trauma
- Pregnant or breastfeeding women
- Prior refractive surgery such as LASIK, RK, or PRK
- Significant complications during surgery or related to Hydrus Microstent resulting in study exit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vold Vision P.L.L.C.
Fayetteville, Arkansas, United States, 72764
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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