Clinical trial NCT04570579: Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement
Official title: Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cataract
Cataract Senile
Presbyopia
Keywords: cataract
presbyopia-correcting intraocular lens
cataract surgery
refractive cataract surgery
Lead sponsor: Sight Medical Doctors PLLC
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Presbyopia-correcting intraocular lenses (PC-IOLs) provide cataract and refractive surgeons with an effective treatment option for presbyopia, allowing patients increased spectacle independence post-cataract surgery. Different IOL designs have been developed based on differing optical principals, such as diffractive, refractive and extended depth of focus (EDOF) design. Most commercially available MFIOLs have two optical zones, one that provides distance vision, and the second that provides near vision (i.e. "bifocal IOLs"). Most recently, trifocal IOLs have been released, with the aim of providing a third (intermediate) focal point, and hence an extended range of vision in pseudophakic patients. While being able to provide patients with near, intermediate and distance vision, most MFIOL's carry the risk of increased visual disturbances, such as glare, starbursts, and halos, which for a small percentage of patients may become quite bothersome or even debilitating.

Extended depth of focus (EDOF) IOLs aim to provide an extended range of vision from intermediate to distance, with a similar visual disturbance profile to their monofocal counterparts. Prior to recent FDA approval, there was only one other EDOF IOL on the market in the US, which, although provides an extended visual range, still had a significant incidence of starbursts and visual disturbances in some patients. FDA approved in February 2020, the Vivity Extended Vision Lens has demonstrated the ability to provide patients with an extended range of vision, excellent contrast sensitivity and visual disturbance profile comparable to a monofocal IOL, as well as high rates of spectacle independence for most activities.

The Vivity Extended Vision IOL (Alcon Laboratories, Fort Worth TX) is an EDOF IOL made of hydrophobic acrylic. This non-diffractive lens was designed to mitigate the effect of presbyopia by providing an extended depth of focus through patented Wavefront Shaping technology. In clinical trials, Vivity has demonstrated significantly better intermediate and near vision as compared to a monofocal IOL, as well as superior spectacle independence scores. Additionally, a validated questionnaire regarding visual disturbances showed the Vivity to have comparable rates of starburst, glare and halos to its monofocal counterpart.

In an era where intermediate vision has become very important (e.g. using laptops, tablets, seeing the dashboard in a car), many patients express desire for visual correction at all possible focal points. Vivity appears to deliver this with minimal visual side effects-even less so as compared to other MFIOL's. This is a valuable aspect of Vivity; spectacle independence is an important factor for many patients-however if this is coupled with debilitating glare, haloes or other visual disturbances, dissatisfaction will ultimately result.

Multiple studies have explored variables that may influence postoperative success of these MFIOLs, including the impact of dry eye, prior corneal refractive surgery, and proper preoperative consent/expectations.

A study has yet to be performed evaluating not only preoperative factors, such as astigmatism, and prior corneal refractive surgery, but also perioperative and intraoperative factors that may also play a role in success of the Vivity IOL implant. In this prospective, nonrandomized "real-world" study, the impact of perioperative factors, such as IOL formulae used, use of femtosecond laser, use of intraoperative aberrometry, as well use of pupillary expansion devices on surgical success will be evaluated. Surgical success will be defined as uncorrected distance, intermediate and near visual acuity (UDVA, UIVA and UNVA, respectively) of 20/40 or better (both monocular and binocular) as well as high levels of patient satisfaction, which will be recorded with a Visual Disturbance Questionnaire, Spectacle Independence Questionnaire, and Visual Quality Questionnaire.

Results will provide never-before-published data on important preoperative as well as perioperative factors that may influence success and patient satisfaction with Vivity IOL implantation

Eligibility criteria: Inclusion Criteria:

* 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.
* 18 years or older
* male or female

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual success - uncorrected distance visual acuity
timeFrame: Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3
measure: Visual success- uncorrected intermediate visual acuity
timeFrame: Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3
measure: Visual success- uncorrected near visual acuity
timeFrame: Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3
measure: Visual success - best corrected distance visual acuity
timeFrame: Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3
measure: Visual success- best-corrected intermediate visual acuity
timeFrame: Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3
measure: Visual success- best-corrected near visual acuity
timeFrame: Change in visual acuity outcomes will be assessed at baseline and compared to postoperative month 3
measure: Visual quality of life measures - visual disturbances
timeFrame: Questionnaires will be administered at baseline visit (preoperative) and at 3 months postoperative
measure: Visual quality of life measures - Visual quality
timeFrame: Questionnaires will be administered at baseline visit (preoperative) and at 3 months postoperative
measure: Visual quality of life measures - spectacle independence
timeFrame: Questionnaires will be administered at baseline visit (preoperative) and at 3 months postoperative
Secondary outcomes:
Other outcomes:
measure: Adverse events
timeFrame: 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)
Locations:
city: Babylon
country: United States
facility: SightMD
state: New York
Study officials:
References:
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