The objective of this study is to prospectively evaluate postoperative visual outcome in a series of patients bilaterally implanted with the AcrySof® IQ ReSTOR® Aspheric +3 D multifocal IOL versus those bilaterally implanted with the LENTIS® Mplus…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Outcome parameter is unilateral uncorrected near visual acuity (40cm).
Secondary outcome
Exploratory outcome measurements include
- Unilateral uncorrected distance and uncorrected intermediate visual acuity
- Bilateral uncorrected distance, near and intermediate vision
- Contrast Sensitivity (unilateral and bilateral)
Range of functional vision using binocular defocus curve with best distance
correction
- Reading speed
Safety parameters include any adverse events during the course of the study.
All adverse events and Alcon product related complaints will be collected at
all study visits. The complete study plan is presented in table 18.1
Background summary
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.
The AcrySof® IQ ReSTOR® +3 D multifocal IOL model SN6AD1 (Alcon Laboratories,
Inc., Fort Worth, TX, USA) has CE certification and has been approved by the US
Food and Drug Administration. This IOL has +3 D of add power at the lens plane,
yielding approximately 2.5 D at the spectacle plane. The AcrySof® IQ ReSTOR® +3
D is a single piece IOL and has a 6 mm optic that consists of a central 3.6 mm
apodized diffractive1 zone and an outer refractive zone. The diffractive zone
facilitates near and distance vision, while the outer refractive zone
facilitates distance vision without loss of light to scatter. The AcrySof® IQ
ReSTOR® +3 D IOL has 9 diffractive steps and incorporates negative spherical
aberration to compensate for positive corneal spherical aberration.
Approximately, 8-12% of the total light is lost due to diffraction.
The LENTIS® Mplus IOL (Oculentis) has CE certification and is an aspheric
refractive bifocal IOL that can be implanted into the eye through a 2.6mm
incision. It is made of a hydrophilic material and is a single piece IOL that
comprises a 6-mm optic with a sector shaped near vision area. This near vision
area has a +3D Add that provides patients with the ability to see up close.
Light is distributed asymmetrically and is dependent upon pupil size.
To date there are no well-controlled, randomized, prospective studies that
compare the visual outcomes of these two different marketed lenses (Alcon
AcrySof IQ ReSTOR +3 SN6AD1 and LENTIS® Mplus).
Study objective
The objective of this study is to prospectively evaluate postoperative visual
outcome in a series of patients bilaterally implanted with the AcrySof® IQ
ReSTOR® Aspheric +3 D multifocal IOL versus those bilaterally implanted with
the LENTIS® Mplus IOL. The primary endpoint is the assessment of unilateral
uncorrected visual acuity at near.
Study design
This study is a post market, subject-masked, randomized, 3 month follow up,
two-arm parallel group clinical investigation to assess the superior
postoperative outcomes with the AcrySof ReSTOR +3 IOL compared to LENTIS® Mplus
IOL.
Intervention
An AcrySof IQ ReSTOR +3.0 D IOL or LENTIS® Mplus IOL, depending on
randomization, will be implanted into the posterior capsule of the first
operative eye (surgeon*s discretion).
Study burden and risks
Removal of the crystalline lens is a delicate but generally safe operation.
There are no added risks compared to the standard operation just because of
this implant.
There is a possibility to 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 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.
After some of the visits patients are not able to drive a car temporarily.
Disadvantages of participation are that the patients have to make additional
visits to the clinic and that visits may take longer. During the follow-up
visits, the ophthalmologist will use an eye drop to dilate the pupil (to
enlarge it). This medication may cause some temporary discomfort (blurred
vision).
Pentagon Park, Boundary Way, Hemel Hempstead
Herts, HP2 7UD
GB
Pentagon Park, Boundary Way, Hemel Hempstead
Herts, HP2 7UD
GB
Listed location countries
Age
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
* are willing and able to understand and sign an informed consent;
* * 1.00 Dioptres of corneal astigmatism in both eyes
* are willing and able to attend postoperative examinations per protocol schedule;
* are at least 21 years of age, of either gender and any race;
* require cataract extraction followed by posterior IOL implantation used as an on-label procedure;
* be willing to have second eye surgery within one month of first eye surgery; Note: The second eye surgery should not be performed less than one week (7 days) after the first eye surgery.
* are in good ocular health, with the exception of cataracts;
* are free of disease(s)/condition(s) listed in the *Caution* section of the AcrySof® ReSTOR® +3 and LENTIS® Mplus package inserts
Exclusion criteria
* Planned multiple procedures, including LRI, during cataract/IOL implantation surgery
* Amblyopia
* Previous corneal surgery
* Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy)
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Diabetic retinopathy
* Macular degeneration
* Subjects with pupil abnormalities (e.g., corectopia)
* History of retinal detachment
* Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
* suturing of incision required at time of surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34631.096.10 |