VISUAL OUTCOMES AFTER BILATERAL SURGICAL CATARACT PHACOEMULSIFICATION: ACRYSOF® RESTOR IOL IMPLANTATION COMPARED TO MONOFOCAL IOL IMPLANTATION

Currently, the standard of care for subjects with cataract is having cataract
surgical removal by phacoemulsification and implantation of a monofocal
intraocular lens, which neither correct for presbyopia or the eventual
associated corneal astigmatism. Therefore subjects are required to purchase
expensive multifocal glasses to correct for near visual acuity and residual
astigmatic error postoperatively.

The objectives of this study are to assess and compare at 6 months 1) the
percentage of subjects achieving bilateral uncorrected distance visual acuity
and bilateral uncorrected near visual acuity <= 0.1 logMar; 2) spectacle
independence at all distances and 3) subject vision-related quality of life
post bilateral implantation of multifocal AcrySof ReSTOR IOLs and Monofocal
IOLs. Secondary outcomes will include cost of eyeglass purchased.

The objectives of this study are to assess and compare at 6 months 1) the
percentage of subjects achieving bilateral uncorrected distance visual acuity
and bilateral uncorrected near visual acuity <= 0.1 logMar; 2) spectacle
independence at all distances and 3) subject vision-related quality of life
post bilateral implantation of multifocal AcrySof ReSTOR IOLs and Monofocal
IOLs.

This study is a postmarket, subject and observer-technician masked, comparative
trial involving the treatment of presbyopia and astigmatism at the time of
cataract surgery and assessment of postoperative resource utilization.

Patients will not know which lenses are being implanted into their eyes. The
study doctor will know which lens the patient receives and he/she will also
determine on which eye surgery will be done on first.

There are 2 groups of subjects:
Group 1 will receive commercially available, CE marked, AcrySof ReSTOR IOL
models (SN6AD1 and SND1T2 through SND1T5)

Group 2 will receive Monofocal IOLs (commercially available, CE marked standard
Monofocal IOL used in clinical practice)

If patients participate they shall have additional visits to the clinic and
visits may take longer than if they would not participate in this study.

All IOLs in the study are intended to improve distance vision improving the
quality of vision far away and may be able to reduce the need for glasses at
distance. The ReSTOR IOL which is a multifocal IOL, patients will have an
increased likelihood of being able to see over a range of distances and may, in
fact, be free of glasses although this cannot be guaranteed. Further, patients
may receive the benefit of information about their health and a chance to be in
a research study that may help others.

Removal of the natural crystalline lens is a delicate but generally safe
operation. There are no added risks to the operation because of the
participation in the study.

Common side effects may include the need for glasses after surgery for near and
intermediate tasks. Less common side effects may include visual disturbance -
halos and glare around lights under night time conditions and blurred vision.
Rare side effects may include infection, reaction to medications used during
surgery, damage to your cornea, swelling (edema), bleeding, requirement for
secondary eye surgery.

Monofocal IOLs are a fixed focus IOL and this means that they only correct
vision for one distance meaning patients will require glasses in order to
conduct all visual tasks after surgery.