What side effects are associated with this type of intervention?

Common treatments for Open-Angle Glaucoma include medications, laser therapy, and surgical interventions such as glaucoma stents. Medications can cause side effects like dry eyes, blurred vision, and systemic effects depending on the drug class. Laser therapies, such as Selective Laser Trabeculoplasty (SLT), may lead to temporary eye irritation, increased intraocular pressure, and inflammation. Glaucoma stents, which are minimally invasive, can cause complications such as infection, bleeding, and stent migration. Extended-Depth-of-Focus (EDOF) lenses used in conjunction with cataract surgery generally have fewer side effects but may include glare and halos around lights.

What prior FDA approvals exist?

The FDA has approved several treatments for Open-Angle Glaucoma that focus on improving aqueous humor outflow and reducing intraocular pressure. Notably, minimally invasive glaucoma surgery (MIGS) devices, such as the iStent and the Hydrus Microstent, have been approved to enhance fluid drainage from the eye. These stents are similar to the glaucoma stent being studied in the trial. Additionally, the FDA has approved various intraocular lenses (IOLs) for cataract surgery, including extended-depth-of-focus (EDOF) lenses like the Symfony lens, which provide a continuous range of vision and reduce the need for glasses post-surgery. These treatments collectively aim to manage intraocular pressure and improve visual outcomes for patients with glaucoma.

What other types of research exist?

Promising novel alternatives for open-angle glaucoma patients in 2024 include multifocal and accommodative intraocular lenses for cataract surgery, which provide improved visual outcomes and reduce the need for glasses. For glaucoma treatment, newer pharmacological treatments, advanced laser therapies, and innovative surgical techniques such as minimally invasive glaucoma surgeries (MIGS) are promising alternatives to traditional stents.

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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR

Secondary study objectives

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 more

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~90

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Open-Angle Glaucoma treatments primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage. Medications like prostaglandin analogs and beta-blockers either increase aqueous humor outflow or decrease its production. Laser therapies, such as Selective Laser Trabeculoplasty (SLT), enhance the drainage of aqueous humor through the trabecular meshwork. Minimally invasive glaucoma surgeries (MIGS), including the use of glaucoma stents, improve aqueous humor outflow by creating new drainage pathways. Extended-Depth-of-Focus (EDOF) lenses, while primarily used to improve vision post-cataract surgery, can be combined with MIGS to provide comprehensive care by addressing both vision correction and IOP management. These treatments are vital for glaucoma patients as they help maintain vision and prevent disease progression.

Effect of topical prostaglandin D2 on the aqueous humor dynamics in rabbits.