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

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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.

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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 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]

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]

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]

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 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]

References

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

[Patients with astigmatism who underwent cataract surgery by phacoemulsification: toric IOL x asferic IOL?]. [2019]

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]

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]

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]

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

[Acrysof(®) toric intraocular lens implantation in cataract surgery]. [2019]

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]

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]

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]