Minimally Invasive Glaucoma Surgery + Cataract Surgery for Glaucoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vold Vision P.L.L.C

Must be taking: Hypotensive medications

Disqualifiers: Previous glaucoma surgery, Moderate glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for people with glaucoma undergoing cataract surgery. It combines an extended-depth-of-focus (EDOF) lens, known as Vivity IOL, which might reduce the need for glasses, with a minimally invasive procedure using a tiny device to lower eye pressure and control glaucoma. The goal is to improve vision and reduce reliance on medications. People with mild open-angle glaucoma and cataracts affecting vision in both eyes might be suitable candidates. Participants should have stable conditions and be able to attend follow-up visits.

As an unphased trial, this study offers patients a unique opportunity to explore innovative treatments that could enhance their quality of life.

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 prior data suggests that this minimally invasive glaucoma surgery and cataract surgery with Vivity IOL is safe?

Research shows that the Vivity intraocular lens (IOL) safely and effectively improves vision. Studies have found that this lens enhances vision at various distances and can reduce the need for glasses. It also has a low risk of causing visual issues like glare or halos, which many find bothersome.

The Hydrus Microstent is already used in a less invasive type of eye surgery to help lower eye pressure, crucial for managing glaucoma. It is designed to reduce the need for medications that lower eye pressure.

Together, the Vivity IOL and Hydrus Microstent aim to improve vision and manage glaucoma safely. Research indicates that patients tolerate these treatments well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vivity IOL treatment for glaucoma and cataracts because it offers a unique combination of minimally invasive glaucoma surgery with cataract surgery. Unlike traditional methods that usually require separate procedures, this approach allows for the simultaneous implantation of the Vivity intraocular lens (IOL) and the Hydrus Microstent. This dual-action method not only addresses vision correction but also helps manage intraocular pressure, a key factor in glaucoma treatment. By combining these surgeries, patients may experience improved vision and better management of their glaucoma with fewer surgeries and a potentially quicker recovery.

What evidence suggests that this trial's treatments could be effective for glaucoma?

Research has shown that the AcrySof IQ Vivity lens improves vision after cataract surgery. In studies, over 88% of patients reported satisfaction with their vision after receiving this lens, and more than 70% could see well at various distances. This lens uses special technology to enable clear vision without glasses. In this trial, participants will receive the Vivity IOL along with the Hydrus Microstent. The Hydrus Microstent lowers eye pressure in people with glaucoma, improving glaucoma management. Together, these treatments aim to enhance vision and reduce the need for glasses and medications. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Vivity IOL

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Vold Vision P.L.L.C

Lead Sponsor

Trials

2

Recruited

50+

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

In a study of 20 patients undergoing combined microincision vitrectomy and cataract surgery, those receiving toric intraocular lenses (IOLs) had significantly better uncorrected visual acuity compared to those with non-toric IOLs at all postoperative time points up to 24 months.

The toric IOLs demonstrated excellent rotational stability, with 80% of lenses remaining within 5° of their intended axis after 24 months, making them a reliable option for correcting corneal astigmatism in patients with vitreoretinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year results of AcrySof toric intraocular lens implantation in patients with combined microincision vitrectomy surgery and phacoemulsification. Lee, JY., Kang, KM., Shin, JP., et al.[2013]

In a study of 149 eyes undergoing cataract surgery, those receiving the AcrySof(®) toric intraocular lens (IOL) showed a significant average reduction of 1.37 cylindrical diopters (CD) of astigmatism, compared to only 0.16 CD in the non-toric group, indicating better astigmatism correction with the toric lens (p<0.001).

The toric IOL group had a higher percentage of patients achieving excellent uncorrected visual acuity (NCVA), with 51.7% reaching 20/20 or 20/25 vision, compared to just 10.93% in the non-toric group, demonstrating the toric lens's efficacy in improving visual outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patients with astigmatism who underwent cataract surgery by phacoemulsification: toric IOL x asferic IOL?]. Torres Netto, Ede A., Gulin, MC., Zapparoli, M., et al.[2019]

In a study of 30 patients undergoing combined 23-gauge microincisional vitrectomy and cataract surgery, the AcrySof toric intraocular lens (IOL) significantly improved uncorrected visual acuity compared to the non-toric IOL at 1, 3, and 6 months post-surgery.

The toric IOL group also had a lower mean absolute residual refractive cylinder, indicating better astigmatism correction, while demonstrating good rotational stability, with 66.7% of lenses remaining within 5° of their intended axis after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study. Park, DH., Shin, JP., Kim, SY.[2022]

Patients with the AcrySof IQ Vivity IOL reported significantly less glare and halo effects in low light conditions compared to those with other multifocal IOLs, indicating a better visual comfort profile.

While the Vivity IOL provided comparable rates of complete spectacle independence to some other IOL types, it was significantly lower than the PanOptix IOL, suggesting that while Vivity offers advantages, it may not achieve the same level of spectacle independence as the best-performing multifocal options.

NCBI (Pubmed)

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. Hovanesian, JA., Jones, M., Allen, Q.[2022]

In a study of 17 patients with glaucoma and extremely shallow anterior chambers, combined 23-gauge pars plana vitrectomy and lensectomy significantly reduced intraocular pressure from an average of 43.14 mmHg to 17.29 mmHg, indicating effective management of glaucoma.

The procedure also increased the anterior chamber depth from 0.507 mm to 3.080 mm and reduced the need for anti-glaucoma medications from an average of 4.1 to 0.6, demonstrating both safety and efficacy without severe complications.

NCBI (Pubmed)

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. Zhang, Z., Zhang, S., Jiang, X., et al.[2018]

In a study of 54 patients who received Acrysof® toric intraocular lenses, the mean uncorrected visual acuity (UCVA) improved to 0.83, with 73.9% achieving a UCVA of 0.8 or better, indicating effective vision correction after surgery.

The lenses significantly reduced preoperative astigmatism from an average of -2.25 diopters to -0.32 diopters postoperatively, demonstrating their efficacy in astigmatism correction with minimal rotation of the lens after implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acrysof(®) toric intraocular lens implantation in cataract surgery]. Zarranz-Ventura, J., Moreno-Montañés, J., Caire Y González-Jáuregui, J., et al.[2019]

In a study of 20 glaucomatous eyes with corneal astigmatism, those implanted with toric intraocular lenses (IOLs) showed significantly better uncorrected visual acuity (UCVA) and less refractive astigmatism compared to those with nontoric IOLs three months after combined minimally invasive glaucoma surgery (MIGS) and cataract surgery.

Postoperative results indicated that 70% of eyes with toric IOLs had 1.0 D or less refractive astigmatism, while only 10% of nontoric IOLs achieved this level, suggesting that toric IOLs are a more effective option for improving visual outcomes in patients with corneal astigmatism.

NCBI (Pubmed)

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. Ichioka, S., Manabe, K., Tsutsui, A., et al.[2021]

Toric intraocular lenses (IOLs) significantly improved uncorrected visual acuity (UCVA) and reduced refractive astigmatism compared to non-toric IOLs in a study of 18 eyes undergoing combined cataract and minimally invasive glaucoma surgery (MIGS).

Postoperatively, 78% of eyes with toric IOLs had 1.0 diopter (D) or less refractive astigmatism, indicating that toric IOLs are an effective option for enhancing visual outcomes in patients with corneal astigmatism.

NCBI (Pubmed)

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. Ichioka, S., Ishida, A., Takayanagi, Y., et al.[2022]

Citations

1.

nature.com

nature.com/articles/s41598-024-69960-w

Functional outcomes and quality of life after AcrySof IQ ...

AcrySof IQ Vivity is a well-tolerated and effective IOL with optimal refractive target for both distant and intermediate vision, needing slight spherical ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11149524/

Visual performance and patient satisfaction with AcrySof® IQ ...

A total of 88.8% of study subjects were satisfied with their postoperative visual outcomes, whereas 87.3% were willing to Vivity IOL in the other eye or were ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9718498/

Long Term Outcomes of a Novel Non-Diffractive Extended ...

100% of AcrySof IQ Vivity subjects had binocular DCIVA 20/40 or better compared to 46.6% of control (p < 0.001). 70.6% of AcrySof IQ Vivity ...

4.

myalcon.com

myalcon.com/international/professional/cataract-surgery/iols/vivity/

AcrySof® IQ Vivity® Extended Depth of Focus IOL | Alcon Global

The first and only presbyopia-correcting IOL with wavefront-shaping technology and a clinically proven monofocal visual disturbance profile.

5.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P930014S126B.pdf

SUMMARY of SAFETY and EFFECTIVENESS DATA (SSED)

The AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015 is indicated for primary implantation for the visual correction of aphakia in adult ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10983649/

Non-diffractive, toric, extended depth-of-focus intraocular ...

The Vivity toric IOL implanted in eyes with low-astigmatism provides accurate refractive outcomes, good visual acuity at different distances and excellent ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06541795?term=AREA%5BInterventionSearch%5D(vivity)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=8

Evaluation of AcrySof IQ Vivity Extended Vision Intraocular ...

The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) ...