Minimally Invasive Glaucoma Surgery + Cataract Surgery for Glaucoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vold Vision P.L.L.C

Must be taking: Hypotensive medications

Disqualifiers: Previous glaucoma surgery, Moderate glaucoma, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that your eye pressure should be stable on your current medication regimen for at least 3 months before surgery, suggesting you may need to continue them.

What data supports the effectiveness of the treatment Vivity IOL, AcrySof IQ Vivity, and AcrySof IQ Vivity Toric for glaucoma?

Research comparing the AcrySof IQ Vivity IOL to other multifocal lenses shows positive patient satisfaction and reduced need for glasses, indicating its effectiveness in improving vision. Additionally, studies on AcrySof toric lenses demonstrate good visual outcomes and stability in patients with cataracts and astigmatism, suggesting potential benefits for those with similar eye conditions.

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Is the AcrySof IQ Vivity IOL safe for use in humans?

The AcrySof IQ Vivity IOL has been studied in various contexts, such as cataract surgery, and has shown positive outcomes in terms of patient satisfaction and visual performance. While specific safety data for glaucoma surgery is not detailed, the lens has been used safely in other eye surgeries.

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How is the Vivity IOL treatment different from other treatments for glaucoma?

The Vivity IOL treatment is unique because it combines a special type of lens (intraocular lens) with cataract surgery and minimally invasive glaucoma surgery (MIGS) to improve vision and reduce astigmatism (a common vision problem) in patients with glaucoma. This approach is particularly beneficial for those with both cataracts and corneal astigmatism, offering better visual outcomes compared to non-toric lenses.

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Eligibility Criteria

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.

Inclusion Criteria

I am 45 years old or older.

My glaucoma is considered stable by my doctor.

Able and willing to comply with follow up visits

Exclusion Criteria

My glaucoma is moderate with specific vision field test results.

Pregnant or breastfeeding women

I have severe or worsening glaucoma despite maximum treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery with an extended-depth-of-focus IOL and minimally invasive glaucoma surgery using the Hydrus Microstent

1 day

1 visit (in-person)

Follow-up

Participants are monitored for visual acuity, refractive outcomes, and patient satisfaction over a 3-month period

3 months

Multiple visits (in-person and virtual)

Participant Groups

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.

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent

Vivity IOL is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vivity IOL for:

• Cataract surgery in patients with glaucoma
• Presbyopia correction

🇪🇺 Approved in European Union as AcrySof IQ Vivity for:

• Cataract surgery
• Presbyopia correction

🇨🇦 Approved in Canada as Vivity IOL for:

• Cataract surgery
• Presbyopia correction

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vold Vision P.L.L.C. Fayetteville, AR

Who Is Running the Clinical Trial?

Vold Vision P.L.L.C Lead Sponsor

Alcon Research Industry Sponsor

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Patients with astigmatism who underwent cataract surgery by phacoemulsification: toric IOL x asferic IOL?]. [2019] Compare the visual acuity of patients who underwent cataract surgery by phacoemulsification with IOL AcrySof(®) toric implantation versus AcrySof(®) IQ and evaluate the reduction of cylindrical diopters (CD) in the postoperative period.

2. England pubmed.ncbi.nlm.nih.gov

Two-year results of AcrySof toric intraocular lens implantation in patients with combined microincision vitrectomy surgery and phacoemulsification. [2013] To evaluate the effects and stability of AcrySof toric intraocular lens (IOL) implantation in patients who had combined microincision vitrectomy surgery (MIVS) and phacoemulsification for vitreoretinal diseases and cataract with corneal astigmatism.

3. New Zealand pubmed.ncbi.nlm.nih.gov

The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence. [2022] To compare patient-reported outcomes (PROs) after intraocular lens (IOL) implantation with the AcrySof IQ Vivity IOL or Vivity Toric IOL to those achieved with other multifocal IOLs.

4. England pubmed.ncbi.nlm.nih.gov

Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study. [2022] To compare AcrySof toric intraocular lens (IOL) and non-toric IOL in patients who had combined 23-gauge microincisional vitrectomy surgery (MIVS) and phacoemulsification for vitreoretinal diseases and cataract with pre-existing corneal astigmatism.

5. Spain pubmed.ncbi.nlm.nih.gov

[Acrysof(®) toric intraocular lens implantation in cataract surgery]. [2019] To assess the medium term outcomes of Acrysof(®) toric intraocular lens implantation in 54 patients (54 eyes).

6. England pubmed.ncbi.nlm.nih.gov

Roles of Toric intraocular Lens implantation on visual acuity and astigmatism in glaucomatous eyes treated with iStent and cataract surgery. [2022] To assess the efficacy of toric intraocular lenses (IOLs) in combined cataract and minimally invasive glaucoma surgery (MIGS), visual and refractive outcomes were compared between eyes implanted with non-toric and toric IOLs during iStent triple procedures.

7. England pubmed.ncbi.nlm.nih.gov

Surgical outcomes of 23-gauge transconjunctival pars plana vitrectomy combined with lensectomy for glaucomatous eyes with extremely shallow anterior chamber and cataract. [2018] Glaucoma combined with an extremely shallow anterior chamber and cataracts remains as a complex condition to deal with. And the emergence of microincision vitrectomy surgery (MIVS) system may provide an ideal option for the treatment of that. We report a clinical study of surgical outcomes of 23-gauge transconjunctival pars plana vitrectomy (PPV) combined with lensectomy in the treatment of glaucomatous eyes with extremely shallow anterior chamber and cataract.

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Toric Intraocular Lens Implantation on Visual Acuity and Astigmatism Status in Eyes Treated With Microhook Ab Interno Trabeculotomy. [2021] Use of toric intraocular lenses is a reasonable option for better visual outcomes when a combined minimally invasive glaucoma surgery (MIGS) and cataract surgery is performed in eyes with corneal astigmatism.