Implantation of a non-diffractive extended depth-of-focus IOL and a monofocal IOL after myopic corneal laser refractive surgery: a randomized controlled trial.

In 1998 the FDA gave the first approval for LASIK (laser in situ
keratomileusis) surgery, a safe procedure to adjust the refractive status of
the cornea in pre-presbyopic and pre-cataract patients.(1) The population of
post-LASIK patients requiring cataract surgery and seeking spectacle
independence is expected to increase in the coming years. However, using
presbyopia correcting multifocal intraocular lenses (mIOLs) after preceding
corneal refractive surgery is controversial due to the potential side-effects
of these mIOLs such as halos and glare, and less predictable postoperative
refractive outcomes. This unpredictability arises from changes of the ratio
between the anterior and posterior corneal curvatures, leading to inaccuracies
in total corneal refractive power estimation and ineffective lens position
predictions with the standard IOL calculation formulas.(2-4)

Currently, the standard care for cataract surgery after corneal laser treatment
involves the implantation of the monofocal AcrySof® IQ SN60WF lens, which is
widely regarded as the standard option. Patients preferring greater spectacle
independence can opt for an Extended Depth of Focus (EDOF) IOL, such as the
Alcon AcrySof® IQ Vivity®, if no medical contraindications exist. However,
these patients must perform co-payment for this EDOF IOL.

The Alcon AcrySof® IQ Vivity® is an EDOF IOL that consists of a central 2.2 mm
wavefront-shaping area with smooth continuous anterior surface transitions from
the periphery to the center for providing the extended focal range. The
wavefront-shaping area stretches and shifts the wavefront, which results in an
extended focal range of > 1.5 diopters (D). This design provides continuous
vision from distance to intermediate distances and preserves the contrast
sensitivity. Besides, this IOL has a monofocal visual disturbance profile
without the halos and glare that are frequently experienced by patients after
mIOL implantation.(5) For this reason, the non-diffractive IOL design could
become a preferred choice for post-LASIK patients.

Despite promising outcomes for EDOF lenses in retrospective and prospective
cohort studies, no robust evidence currently supports their superiority over
monofocal lenses in post-corneal laser patients.(6-8) Moreover, post-LASIK
patients face an increased risk of residual refractive error (target deviation)
after IOL implantation, with the risk and its impact on visual acuity varying
by lens design. Scientific data on the risks and visual impact of such
deviations remain limited, further emphasizing the need for a comparative study.
This study aims to address this knowledge gap by conducting a double-masked,
randomized, prospective clinical trial comparing the visual function of
bilateral non-diffractive advanced monofocal Alcon AcrySof® IQ Vivity® IOL
implantation with the standard Alcon monofocal AcrySof® IQ SN60WF IOL, both
targeted for mini-monovision, in patients with previous myopic laser corneal
surgery. By providing insight into visual performance, this trial seeks to
clarify whether the EDOF IOL offers significant advantages over the monofocal
IOL in this specific patient group.


References:
1. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD,
et al. LASIK world literature review: quality of life and patient satisfaction.
Ophthalmology. 2009;116(4):691-701.
2. Seitz B, Langenbucher A, Nguyen NX, Kus MM, Küchle M. Underestimation of
intraocular lens power for cataract surgery after myopic photorefractive
keratectomy11The authors have no proprietary interest in the development or
marketing of this or any competing instrument or piece of equipment.
Ophthalmology. 1999;106(4):693-702.
3. Chan TC, Liu D, Yu M, Jhanji V. Longitudinal evaluation of posterior corneal
elevation after laser refractive surgery using swept-source optical coherence
tomography. Ophthalmology. 2015;122(4):687-92.
4. Wang L, Hill WE, Koch DD. Evaluation of intraocular lens power prediction
methods using the American Society of Cataract and Refractive Surgeons
Post-Keratorefractive Intraocular Lens Power Calculator. J Cataract Refract
Surg. 2010;36(9):1466-73.
5. van Amelsfort T, Webers VSC, Bauer NJC, Clement LHH, van den Biggelaar F,
Nuijts R. Visual outcomes of a new nondiffractive extended depth-of-focus
intraocular lens targeted for minimonovision: 3-month results of a prospective
cohort study. J Cataract Refract Surg. 2022;48(2):151-6.
6. Bucci FA, Jr. Patient Satisfaction, Visual Outcomes, and Regression Analysis
in Post-LASIK Patients Implanted With Multifocal, EDOF, or Monofocal IOLs. Eye
Contact Lens. 2023;49(4):160-7.
7. Christopher KL, Miller DC, Patnaik JL, Lynch AM, Davidson RS, Taravella MJ.
Comparison of Visual Outcomes of Extended Depth of Focus Lenses in Patients
With and Without Previous Laser Refractive Surgery. J Refract Surg.
2020;36(1):28-33.
8. Ferreira TB, Pinheiro J, Zabala L, Ribeiro FJ. Comparative analysis of
clinical outcomes of a monofocal and an extended-range-of-vision intraocular
lens in eyes with previous myopic laser in situ keratomileusis. J Cataract
Refract Surg. 2018;44(2):149-55.

The primary objective of this study is to compare the mean binocular DCIVA at
66 cm under photopic conditions 3 months after cataract surgery, in a series of
patients, who previously underwent myopic laser surgery, bilaterally implanted
with the non-diffractive advanced monofocal AcrySof® IQ Vivity® IOL
(intervention-group) versus the Alcon monofocal AcrySof® IQ SN60WF IOL
(control-group) both targeted for mini-monovision.

The design of this study is a multicenter, double masked, prospective
randomized controlled trial. Patients who previously underwent myopic corneal
refractive surgery on both eyes and now suffering from cataract which requires
cataract surgery on both eyes will be included in the study. This study will be
conducted in 3 different centers in 2 different countries.
The study consists of two study-groups: intervention group (bilateral
implantation with the non-diffractive advanced monofocal AcrySof® IQ Vivity®
IOL) and the control-group (bilateral implantation with the Alcon monofocal
AcrySof® IQ SN60WF IOL both targeted for mini-monovision. A total of 48
patients will be randomized into either the intervention-group or the
control-group at a 1:1 ratio. Patients and study-optometrists/research
assistants doing the postoperative measurements will be masked. Surgeons are
impossible to mask, due to the difference in (optical) design between both
IOLs. All surgeries will be performed by experienced surgeons, performing >250
cataract surgeries per year. Cataract extraction will be performed using either
the conventional or Femtosecond-laser assisted cataract surgery, according to
the preference of the surgeon.

The IOL power calculation will be performed according to the optical biometry
assessment of the IOLMaster700 and the Barrett True K formula will be used
among all participants, using the Barrett True K toric calculator. The surgeons
will use their personalized lens constants for optimal results. The power
calculation will be targeted on mini-monovision in all participants, for the
dominant eye we choose an emmetropic target closest to zero, and the
non-dominant eye a myopic target between -0.25 and -0.75D is selected. Eye
dominance is determined using the Miles test (triangle test).

Patients will be examined pre-operatively and 1 week, and 1 and 3 months
postoperatively. All patients will undergo delayed sequential bilateral
cataract surgery (DSBCS) with the following post-operative examinations: one
week after surgery of the first operated eye, one week after surgery of the
second operated eye, and 1-, and 3-months postoperative visits at which both
eyes will be examined in the same visit. Both eyes are examined simultaneously
at 1, and 3 months postoperatively in order to minimize the number of
postoperative follow-up visits for patients. Consequently, with DSBCS, at 1
months postoperatively, the first eye will be 5 weeks after surgery and the
second eye 3 weeks. At 3 months postoperatively, the first eye will be 13 weeks
after surgery and the second eye 11 weeks. We assume that this time difference
does not affect the results.

All patients will receive a standard cataract surgery on both eyes with the
phacoemulsification technique. One group receives bilateral implanation with
the AcrySof IQ Vivity IOL (EDOF IOL - intervention-group) and the other group
receives bilateral implanation with the AcrySof IQ Monofocal IOL (Monofocal IOL
- controlgroup). total of 48 patients will be randomized into either the
intervention-group or the control-group at a 1:1 ratio.

In this study, all participants will receive their cataract surgery according
to standard procedure. As with any type of intraocular surgery, there is a
possbility of complications due to anesthesia, drug reactions, and surgical
problems. Both Alcon AcrySof Vivity and Monofocal IOLs, used in this study, are
CE-marked and commercially available in the countries in which the study will
be conducted.
Postoperatively, there will be one extra postoperative visit in addition to the
standard cataract surgery follow-up. All additional measurements during this
visit are non-invasive. And lastly, the participants will be asked to fill out
questionnaires at 3 months posoperatively regarding patient satisfaction,
quality of vision and spectacle independence.
Postoperatively there may still be residual refractive errors leading to a
suboptimal patient satisfaction. Laser-treatment or spectacles may be needed to
correct these errors. In addition, optical disturbances (halos and glare) can
occur postoperatively, but usually these become less apparent after
neuroadaptation has taken place. According to the literature, EDOF and
monofocal IOLs carry comparable risks for these optical disturbances after
surgery.
Enrolled patients will receive travel compensation during the last
postoperative visit (¤0.,19 per km). If participants travel by public
transport, a full refund for these costs will be offered.