Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement

NCT04570579 | Active Not Recruiting FDA Device

• 1 other identifier: EDOF Lifestyle Enhancement
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The introduction of presbyopia-correcting intraocular lenses (PC-IOLs) has provided cataract and refractive surgeons the ability to provide patients with a wider range of visual success and spectacle independence post-cataract surgery.Multifocal (MFIOL) IOLs have the ability to provide near and distance vision, and in the case of trifocal IOLs, near, intermediate and distance. Despite the significant technological evolution of MFIOL's, the potential for visual disturbances, such as glare, halos and starbursts still exists-and in much greater frequency compared to their monofocal counterparts. Extended depth of focus (EDOF) IOLs aim to provide patients with a functional range of vision, with a similar visual disturbance profile to a monofocal lens. In this way, this subset of PC-IOL's can offer patients some degree of spectacle independence, with a significantly lower incidence of visual disturbances. The Vivity Extended Vision IOL is the first of its kind to offer Wavefront Stretching technology, providing patients with an excellent extended range of vision from intermediate to distance, as well as some functional near vision. Prior studies have demonstrated very good vision in both bright and dim lighting conditions, as well as a high degree of spectacle independence with the Vivity IOL, as compared to a monofocal IOL. Studies evaluating the ability of the Vivity IOL to provide a significant impact on patient lifestyle (e.g. patient independence from spectacles for most activities with a low rate of visual disturbances) in the United States in a 'real-world' setting have yet to be performed. In addition, influence of pre-and-perioperative variables such as sex, age, prior refractive surgery, IOL formula used, axial length, astigmatism, use of intraoperative aberrometry, femtosecond laser and pupillary expansion devices has yet to be evaluated on the postoperative success of this IOL. This study will be comprised of patients with visually significant cataracts who will undergo cataract extraction with implantation of the spherical and/or toric models of the Vivity Extended Vision (Alcon, Fort Worth TX) intraocular lens. Upon decision of the patient and surgeon to undergo surgery, patients will be offered the option to enroll in this observational study.

Conditions

Cataract; Cataract Senile; Presbyopia

Keywords

cataract; presbyopia-correcting intraocular lens; cataract surgery; refractive cataract surgery

Outcome Measures

Primary Outcomes (9)

• Visual success - uncorrected distance visual acuity

  Change in uncorrected distance visual acuity between baseline and at 3 months postoperative will be assessed.

  Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3

• Visual success- uncorrected intermediate visual acuity

  Change in uncorrected intermediate visual acuity between baseline and at 3 months postoperative will be assessed.

  Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3

• Visual success- uncorrected near visual acuity

  Change in uncorrected near visual acuity between baseline and at 3 months postoperative will be assessed.

  Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3

• Visual success - best corrected distance visual acuity

  Change in best-corrected distance visual acuity between baseline and at 3 months postoperative will be assessed.

  Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3

• Visual success- best-corrected intermediate visual acuity

  Change in best-corrected intermediate visual acuity between baseline and at 3 months postoperative will be assessed.

  Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3

• Visual success- best-corrected near visual acuity

  Change in best-corrected near visual acuity between baseline and at 3 months postoperative will be assessed.

  Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3

• Visual quality of life measures - visual disturbances

  Change in responses in regard to patient lifestyle satisfaction using a Visual Disturbance Questionnaire at baseline and 3 months postoperative will be assessed. This will be assessed on a scale of 0 - 4 in severity (0 = no disturbance, 4 = very bothersome disturbance). Total scores will be tallied and compared between baseline and postoperative month 3 responses.

  Questionnaires will be administered at baseline visit (preoperative) and at 3 months postoperative

• Visual quality of life measures - Visual quality

  Change in responses in regard to patient lifestyle satisfaction using a Visual Quality Questionnaire at baseline and 3 months postoperative will be assessed. This will be assessed on a scale of 1 - 5 in severity (1 = no issues with vision interfering with daily activities, 5 = vision interfering with nearly every activity listed). Total scores will be tallied and compared between baseline and postoperative month 3 responses.

  Questionnaires will be administered at baseline visit (preoperative) and at 3 months postoperative

• Visual quality of life measures - spectacle independence

  Change in responses in regard to patient lifestyle satisfaction using a Spectacle Independence Questionnaire at baseline and 3 months postoperative will be assessed. This will be assessed on a scale of 0 - 4 in severity (0 = never using spectacles for activities, 4 = always using spectacles for every activity listed). Total scores will be tallied and compared between baseline and postoperative month 3 responses.

  Questionnaires will be administered at baseline visit (preoperative) and at 3 months postoperative

Other Outcomes (1)

• Adverse events

  Safety measures and assessment for adverse events will be assessed at all time points (baseline, postoperative day 1, postoperative week 1, postoperative month 1, postoperative month 3)

Study Arms (1)

Observational cohort

This is a prospective, nonrandomized study of patients undergoing bilateral cataract surgery with implantation of the spherical Vivity and/or Vivity toric IOL. Preoperative patient data such as age, sex, prior ocular history, medical history, and intraocular lens calculations/formulae used will be recorded. Uncorrected and best-corrected visual acuity will be measured at distance (4m), intermediate (60cm) and near (40cm). All 3 surveys will be administered prior to surgery (at baseline) and at 3 months postoperative, regarding spectacle independence, visual disturbances, and visual quality. A proper perioperative record will be maintained, documenting planned IOL implantation, actual IOL implant used, use of femtosecond laser, use of intraoperative aberrometry, and use of pupillary expansion devices. Patients will be examined 1 day ("postoperative day 1)", 1 week ("postoperative week 1"), 1 month ("postoperative month 1") and 3 months ("postoperative month 3") following surgery.

Device: Vivity Extended Depth of Focus Intraocular Lens

Interventions

Vivity Extended Depth of Focus Intraocular Lens DEVICE

Patients selected to have bilateral sequential cataract surgery using the Vivity (spherical and/or toric where applicable) intraocular lens implant will subsequently be offered enrollment into this observational study. Visual outcomes will be recorded at postoperative day 1, week 1, month 1 and month 3.

Observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be enrolled from a large clinical ophthalmic practice after having been determined to have visually significant cataracts requiring cataract surgery.

You may qualify if:

• Visually significant bilateral cataracts, with planned cataract extraction using phacoemulsification and clear corneal incision
• Ability to comprehend and willing to sign informed consent
• Ability to complete all required postoperative follow up procedures.
• years or older
• male or female

You may not qualify if:

• Patients who lack ability to consent, and who cannot provide clear understanding of the surgical procedure as well as possible adverse side effects (e.g. dysphotopsias) of the IOL will be excluded
• Patients who are professional night drivers, pilots and those with other occupations for whom induced dysphotopsia could put their career at risk will be excluded
• Patients who have preexisting significant ocular pathology, including severe dry eye, retina, optic nerve (including moderate-severe glaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significant scarring), limiting or affecting visual potential, in the opinion of the surgeon, will be excluded
• Patients whose IOL calculations are outside the range available for the Vivity IOL will be excluded.
• Patients who have history of past eye trauma with evidence of/suspected zonular laxity, and those with pseudoexfoliation will be excluded.
• Patients with prior corneal surgery (namely, radial keratotomy (RK), corneal transplantation of any kind) will be excluded from the study (post-myopic and hyperopic LASIK and PRK patients will be permitted to participate in the study).
• Pregnant and/or lactating patients will be excluded from the study.
• Patients with perioperative or intraoperative complications that do not allow for implantation of the Vivity IOL will be excluded.
• Inability to implant the Vivity IOL will cause immediate release from the study with documented rationale for exit.

Sponsors & Collaborators

• Alanna Nattis, DO: lead

Study Sites (1)

SightMD

Babylon, New York, 11702, United States

Location

Related Publications (8)

• Lichtinger A, Rootman DS. Intraocular lenses for presbyopia correction: past, present, and future. Curr Opin Ophthalmol. 2012 Jan;23(1):40-6. doi: 10.1097/ICU.0b013e32834cd5be.

  PMID: 22081027 BACKGROUND

• Alfonso JF, Fernandez-Vega L, Puchades C, Montes-Mico R. Intermediate visual function with different multifocal intraocular lens models. J Cataract Refract Surg. 2010 May;36(5):733-9. doi: 10.1016/j.jcrs.2009.11.018.

  PMID: 20457363 BACKGROUND

• de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.

  PMID: 23332253 BACKGROUND

• Wang SY, Stem MS, Oren G, Shtein R, Lichter PR. Patient-centered and visual quality outcomes of premium cataract surgery: a systematic review. Eur J Ophthalmol. 2017 Jun 26;27(4):387-401. doi: 10.5301/ejo.5000978. Epub 2017 Apr 24.

  PMID: 28574135 BACKGROUND

• Cochener B, Boutillier G, Lamard M, Auberger-Zagnoli C. A Comparative Evaluation of a New Generation of Diffractive Trifocal and Extended Depth of Focus Intraocular Lenses. J Refract Surg. 2018 Aug 1;34(8):507-514. doi: 10.3928/1081597X-20180530-02.

  PMID: 30089179 BACKGROUND

• de Medeiros AL, Jones Saraiva F, Iguma CI, Kniggendorf DV, Alves G, Chaves MAPD, Vilar C, Motta AFP, Carricondo PC, Takashi Nakano C, Nose W, Hida WT. Comparison of visual outcomes after bilateral implantation of two intraocular lenses with distinct diffractive optics. Clin Ophthalmol. 2019 Aug 29;13:1657-1663. doi: 10.2147/OPTH.S202895. eCollection 2019.

  PMID: 31695317 BACKGROUND

• Savini G, Schiano-Lomoriello D, Balducci N, Barboni P. Visual Performance of a New Extended Depth-of-Focus Intraocular Lens Compared to a Distance-Dominant Diffractive Multifocal Intraocular Lens. J Refract Surg. 2018 Apr 1;34(4):228-235. doi: 10.3928/1081597X-20180125-01.

  PMID: 29634837 BACKGROUND

• Williams D, Yoon GY, Porter J, Guirao A, Hofer H, Cox I. Visual benefit of correcting higher order aberrations of the eye. J Refract Surg. 2000 Sep-Oct;16(5):S554-9. doi: 10.3928/1081-597X-20000901-12.

  PMID: 11019871 BACKGROUND

Related Links

• FDA Summary of Safety and Effectiveness Data: Vivity Extended Vision IOL
• Acrysof IQ Vivity Intraocular Lens Product Information

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Research, Ophthalmologist

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 30, 2020
• Study Start: October 14, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)