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Intraocular Lens
Minimally Invasive Glaucoma Surgery + Cataract Surgery for Glaucoma
N/A
Recruiting
Research Sponsored by Vold Vision P.L.L.C
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial tests a lens to reduce need for glasses and a stent to reduce glaucoma meds after cataract surgery.
Who is the study for?
This trial is for adults over 45 with mild open-angle glaucoma and age-related cataracts, without severe vision loss or eye surgery history. Participants should have stable glaucoma and be on up to three pressure-lowering meds. They must be able to see well after surgery and follow the study schedule.Check my eligibility
What is being tested?
The study tests how a special lens implant (Vivity IOL) during cataract surgery affects vision in glaucoma patients. It also examines the effects of a minimally invasive stent procedure aimed at reducing eye pressure and medication needs post-surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort, redness, or inflammation in the eye; temporary blurred vision; increased eye pressure requiring additional treatment; or rare complications from the stent placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Secondary outcome measures
Mean Absolute Prediction Error
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
+7 moreOther outcome measures
IOL patient satisfaction (IOLSAT) questionnaire
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vivity IOL
2020
N/A
~40
Find a Location
Who is running the clinical trial?
Vold Vision P.L.L.CLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Alcon ResearchIndustry Sponsor
704 Previous Clinical Trials
124,486 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 45 years old or older.My glaucoma is considered stable by my doctor.My glaucoma is moderate with specific vision field test results.My eye's drainage angles are widely open.I have severe or worsening glaucoma despite maximum treatment.My eye's nerve layer has been stable for at least a year before surgery.I have had surgery for glaucoma before.I have been diagnosed with mild open-angle glaucoma.I have not had laser eye surgery in the last 90 days.I have had surgery to correct my vision.My vision field and nerve health match glaucoma conditions but aren't severe.I have cataracts in both eyes that affect my vision.My vision has been stable for at least a year before surgery.My eye pressure is 25 or lower on up to 3 medications.My glaucoma is not caused by common open-angle types.I had no major issues during my eye surgery.My eye pressure has been stable on my current meds for at least 3 months before surgery.Both of my eyes will be operated on within 21 days of each other.I will leave the trial if I have major vision problems from the Hydrus Microstent.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor actively recruiting participants?
"According to clinicaltrials.gov, this research endeavour is no longer actively recruiting patients. Initially posted on November 30th 2022, the trial was last updated on November 21st 2022. Despite that, there are over 300 other trials accepting volunteers at present."
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