Intraocular Lenses for Cataracts

No longer recruiting at 66 trial locations

Overseen By Celia Busby

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bausch & Lomb Incorporated

Disqualifiers: Macular degeneration, Glaucoma, Retinal detachment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of intraocular lenses (IOLs), enVista Aspire and Aspire Toric. The goal is to evaluate their effectiveness in people with cataracts, which cause cloudy vision. Participants will provide insights into patient and surgeon satisfaction with these lenses. Individuals with cataracts that reduce vision to 20/40 or worse, and who are expected to improve to 20/30 or better after lens implantation, are suitable candidates for the trial. As an unphased trial, this study allows participants to contribute to the understanding of new lens options for cataract treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these intraocular lenses are safe for cataract patients?

Research has shown that the enVista Aspire and Aspire Toric ETA intraocular lenses (IOLs) are generally well-tolerated by patients. In past studies, individuals with these lenses experienced good vision results, comparable to those with traditional lenses. The lenses remained securely in place in the eye for up to 180 days after surgery, indicating they function as expected.

Significant problems related to these lenses have not been reported in the information provided. These IOLs treat cataracts and astigmatism, and their safety is supported by their similarity to other approved lenses. This suggests they are safe for most people, but individual experiences may vary. Always consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the enVista Aspire EA and Aspire Toric ETA intraocular lenses (IOLs) because they offer advanced features for cataract treatment. These IOLs are designed to improve visual quality by reducing chromatic aberration, which can lead to clearer vision than standard monofocal lenses. Additionally, the Aspire Toric ETA IOLs specifically address astigmatism, providing a tailored solution for patients who also have this condition. This combination of precise vision correction and astigmatism management sets them apart from typical IOLs, potentially enhancing overall patient satisfaction and visual outcomes.

What evidence suggests that enVista Aspire EA or Aspire Toric ETA IOLs are effective for cataracts?

Research has shown that the enVista Aspire and Aspire Toric lenses for cataract surgery are promising. In a study with five participants using the toric lens, all experienced good results with both natural and corrected distance vision. Another study found that the toric lens corrected astigmatism, a common issue for those with cataracts, while maintaining stable vision. The enVista Aspire lenses are also known for staying in place, which is crucial for clear vision. Overall, these lenses have proven effective, making them a strong choice for cataract surgery. Participants in this trial will receive bilateral implants of either the enVista Aspire EA or Aspire Toric ETA IOLs to further evaluate their effectiveness. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing cataract extraction who are suitable candidates for intraocular lens implantation. Specific eligibility criteria details were not provided, so it's best to consult the study team or your doctor.

Inclusion Criteria

I am 22 years old or older.

Subjects must require an IOL power from +6.0 diopter (D) to +34.0 diopter (D) in both eyes

Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures

Exclusion Criteria

I have cataracts due to rubella, birth defects, injury, or complications.

I have significant loss of the gel-like substance inside my eye.

Pre-existing ocular conditions that may negatively impact the stability of the implant or intraoperative conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract extraction and are bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs

1 day

Postoperative Follow-up

Participants are monitored for visual acuity and satisfaction after IOL implantation

2-6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• enVista Aspire EA or Aspire Toric ETA IOLs

Trial Overview The study is testing two types of lenses: enVista Aspire (EA) and Aspire Toric (ETA), which are implanted during cataract surgery. The goal is to assess how well these lenses perform in real-world conditions and patient satisfaction with the results.

How Is the Trial Designed?

Group I: Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs Experimental Treatment 1 Intervention

enVista Aspire EA or Aspire Toric ETA IOLs is already approved in United States, European Union for the following indications:

Approved in United States as enVista Aspire for:

• Visual correction of aphakia following removal of a cataractous lens

Approved in European Union as enVista Aspire for:

• Visual correction of aphakia following removal of a cataractous lens

Approved in United States as Aspire Toric for:

• Visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision

Approved in European Union as Aspire Toric for:

• Visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University

Published Research Related to This Trial

In a study of 37 patients with developmental cataracts, implantation of toric multifocal intraocular lenses (TMIOLs) resulted in significant improvements in visual acuity, with uncorrected distance vision improving from 0.93 to 0.08 logMAR after one year.

Patients with cortical and nuclear cataracts experienced better visual outcomes and satisfaction compared to those with posterior subcapsular cataracts, who reported more issues with near vision and photic phenomena.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of visual outcomes in adult patients with different types of developmental cataracts after toric multifocal intraocular lenses implantation. Shen, J., Ma, D., Cai, L., et al.[2023]

In a study of 517 subjects, the AcrySof Toric intraocular lens (IOL) demonstrated superior visual acuity outcomes compared to a spherical control IOL, with 77.7% of patients achieving 20/20 vision or better after one year.

The AcrySof Toric IOL also showed excellent rotational stability, with an average rotation of less than 4°, and significantly higher rates of spectacle freedom (61.0% vs. 36.4% for the control IOL), indicating its effectiveness for patients with cataracts and corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study. Holland, E., Lane, S., Horn, JD., et al.[2022]

Toric intraocular lenses (IOLs) are increasingly used in cataract surgery and are effective for correcting astigmatism, making them a reliable option for patients with this condition.

The paper discusses various models of pseudophakic toric IOLs, including both monofocal and multifocal lenses, and outlines their indications for treating both regular and irregular astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Toric IOL's]. Levy, P.[2012]

Modern cataract surgery replaces the natural lens with advanced intraocular lenses (IOLs) that can correct vision at multiple distances, reducing the need for glasses after surgery.

These new IOLs include multifocal, toric, and extended depth of focus options, which not only improve visual quality but also enhance the overall quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[NEW LENSES IN MODERN CATARACT SURGERY]. Friehmann, A., Assia, EI.[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]

In a study of 51 eyes from 39 patients, the Precizon Toric IOL demonstrated excellent visual outcomes after cataract surgery, with 98% of eyes achieving uncorrected distance visual acuity (UDVA) of 0.3 logMAR or better at the 4-month follow-up.

The IOL showed high predictability in refractive results, with 86% of eyes within ±0.50 D of the intended correction, and maintained good rotational stability with minimal axis rotation, indicating its effectiveness for patients with astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes After Cataract Surgery With a New Transitional Toric Intraocular Lens. Ferreira, TB., Berendschot, TT., Ribeiro, FJ.[2022]

In a study of 32 eyes from 24 patients who received toric intraocular lenses (IOLs) for cataract surgery, 81% experienced improved unaided visual acuity (UVA) post-surgery, indicating the efficacy of toric IOLs in enhancing vision.

While most patients achieved good refractive outcomes, with 94% within ±1.5 diopters of the predicted spherical equivalent, there is a 9% risk of significant IOL rotation requiring further surgery, highlighting a safety consideration for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world refractive outcomes of toric intraocular lens implantation in a United Kingdom National Health Service setting. Xue, K., Jolly, JK., Mall, SP., et al.[2019]

In a study of 117 patients undergoing bilateral implantation of toric intraocular lenses (IOLs) for cataracts and astigmatism, 99% achieved a binocular uncorrected distance visual acuity of 20/40 or better, demonstrating high efficacy in improving vision.

Patients reported high satisfaction with their vision post-surgery, with 94% rating their satisfaction as 7 or higher, and 69% of patients reported never needing distance spectacles after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual function and patient experience after bilateral implantation of toric intraocular lenses. Ahmed, II., Rocha, G., Slomovic, AR., et al.[2022]

Citations

1. bauschsurgical.com bauschsurgical.com/resources/peer-opinions/the-envista-aspire-toric-advantage/

The enVista Aspire ™ Toric Advantage In the five patients who received the toric lens, good outcomes were observed in uncorrected and corrected distance and intermediate vision, with 100% and 80% ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06594185/a-study-to-evaluate-real-world-outcomes-of-the-envistar-aspire-ea-and-aspire-toric-eta-intraocular-lens-in-subjects-undergoing-cataract-extraction?state=CA&city=Upland

A Study to Evaluate Real World Outcomes of the enVista® ... A study to evaluate the real-world clinical performance of the enVista Aspire and Aspire Toric intraocular lens (IOL) models EA and ETA and to assess surgeon ...

3. withpower.com withpower.com/trial/phase-cataract-7-2024-a015c

Intraocular Lenses for Cataracts · Info for Participants In a study of 51 eyes from 39 patients, the Precizon Toric IOL demonstrated excellent visual outcomes after cataract surgery, with 98% of eyes achieving ...

4. bauschsurgical.com bauschsurgical.com/siteassets/pdf/envista_aspire_surgeon_brochure_easp0004usa23v3.pdf

enVista Aspire™ Toric alignment and rotational stability are vital for patient satisfaction and visual outcomes. 1° Lens Rotation. Effectiveness 96.7%13. 180° mark. Intended.

5. westlakeeyes.com westlakeeyes.com/envista-aspire-toric-lens/

enVista Aspire Toric Lens - Westlake Eye Specialists The enVista Aspire Toric IOL is designed to correct astigmatism while also delivering the visual benefits of Bausch + Lomb's proven enVista platform—most ...

6. bauschsurgical.com bauschsurgical.com/cataract/enVista-Aspire/

enVista Aspire Correcting cataracts and astigmatism. BOTH at the same time. · The enVista® toric platform delivers proven rotational stability through 180 days post-surgery ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06594185?term=SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DUnited%20States%20AND%20AREA%5BLocationState%5DOregon%20AND%20AREA%5BLocationCity%5DBend)&rank=7

A Study to Evaluate Real World Outcomes of the enVista® ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

8. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-real-world-outcomes-of-the-envista-r-aspire-ea-and-aspire-toric-eta-intraocul

A Study to Evaluate Real World Outcomes of the enVista ... A study to evaluate the real-world clinical performance of the enVista Aspire and Aspire Toric intraocular lens (IOL) models EA and ETA and ...