A randomized, subject-blinded evaluation of visual function after bilateral implantation of two types of presbyopia-correcting multifocal IOLs

Presbyopia is a progressive decline in the ability to focus on near objects
with increasing age. Conventional management of presbyopia has been through
bifocal and multifocal progressive spectacle lenses or contact lenses. Recent
advances in technology have allowed surgical correction of presbyopia through
intraocular lenses (IOLs) among patients undergoing cataract extraction or
refractive lens exchange. Presbyopia correcting IOLs are becoming increasingly
popular as they may help achieve freedom from spectacles. Two types of
presbyopia correcting IOLs are the multifocal FineVision Micro F IOL and the
multifocal AcrySof® IQ ReSTOR® +3 IOL.
Although the FineVision Micro F IOL has the potential to have better
intermediate vision without loss of far and near vision compared to the
AcrySof® IQ ReSTOR® +3 IOL, this has never been evaluated in a well-controlled,
randomized, prospective study.

The objective of this study is to prospectively evaluate postoperative visual
outcomes in a series of patients bilaterally implanted with the FineVision
Micro F IOL versus those bilaterally implanted with the AcrySof® IQ ReSTOR®
Aspheric +3 D multifocal IOL.

The study design is a randomised clinical study to compare outcomes after
implantation with the FineVision versus implantation with the AcrySof ReSTOR. A
total of 28 patients will be randomised into either the FineVision group or the
AcrySof ReSTOR group at a 1:1 ratio. Patients will receive standard cataract
extractions with implantation of an IOL in both eyes. Patients will be examined
pre-operatively and 1 week, and 1, 3 and 6 months postoperatively. The duration
of the study is 15 months, based on the inclusion of patients into the RCT in
the first 6 months, a follow-up of 6 months after IOL implantation and analysis
of the data during the last 3 months of the study.

The intervention will be bilateral cataract surgery with implantation of a
multifocal IOL.

Patients will be followed-up according to the cataract standard of care. In
addition to the standard of care, aberrometry measurements will be performed
preoperatively and 1, 3 and 6 months postoperatively. Furthermore, additional
visual acuity measurements, contrast sensitivity testing and reading speed test
will be performed. To evaluate vision-specific quality-of-life, patient
questionnaires will be used.
Patients randomized and enrolled in this clinical study have 100% assurance of
having a multifocal IOL implanted into their eyes that provides the greatest
likelihood of spectacle freedom following cataract extraction and IOL
implantation. These lenses are not the standard of care in cataract surgery and
are not reimbursed. All IOL models used in this clinical study are CE-marked
and commercially available in The Netherlands. There is a possibility patients
may experience a halo type effect around lights at night. Also, some patients
might experience glare after surgery, which is the sensation of seeing through
a foggy window. Experience with these lenses indicates that these symptoms
reduce with time, but might not completely disappear. Although these lenses
decrease the likelihood for spectacle wear, they do not necessary eliminate the
need for them for all tasks and as such spectacles may be needed to improve
vision in some instances.