The primary objective is to demonstrate non-inferiority of patients bilaterally implanted with the AcrySof® IQ ReSTOR® +2.5 D MIOL to AcrySof® IQ ReSTOR® +2.5 D MIOL in the dominant eye and AcrySof® IQ ReSTOR® +3.0 D in the fellow eye in binocular…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Binocular distance corrected visual acuity at 60 cm at Visit 3A (90 ± 14 days).
Secondary outcome
Binocular distance corrected visual acuity at 40 cm at Visit 3A (90 ± 14 days).
Background summary
The standard treatment for a cataract is surgical removal of the natural lens.
This is usually replaced by a *monofocal* IOL. This is comparable to a contact
lens being implanted inside the eye. With *monofocal* IOLs, one can only see
clearly at a distance. Therefore the patient will also need glasses to see well
at a short or middle distance.
*Multifocal* Intraocular lenses have been available for more than 20 years.
They make it possible to see both at a distance and close up or in the middle
distance at the same time.
Study objective
The primary objective is to demonstrate non-inferiority of patients bilaterally
implanted with the AcrySof® IQ ReSTOR® +2.5 D MIOL to AcrySof® IQ ReSTOR® +2.5
D MIOL in the dominant eye and AcrySof® IQ ReSTOR® +3.0 D in the fellow eye in
binocular distance corrected visual acuity at 60 cm at Visit 3A (90 ± 14 days).
The secondary objective is to demonstrate non-inferiority of patients
bilaterally implanted with the AcrySof® IQ ReSTOR® +2.5 D MIOL to AcrySof® IQ
ReSTOR® +2.5 D MIOL in the dominant eye and AcrySof® IQ ReSTOR® +3.0 D in the
fellow eye in binocular distance corrected visual acuity at 40 cm at Visit 3A
(90 ± 14 days).
Study design
This is a prospective, randomized, patient-masked study requiring implantation
of the AcrySof® IQ ReSTOR® +2.5 D MIOL in the dominant eye and randomization to
either the AcrySof® IQ ReSTOR® +2.5 D MIOL or AcrySof® IQ ReSTOR® +3.0 D MIOL
in the fellow eye of approximately 100 patients (200 eyes). Post IOL
implantation, patients will be assessed at 1-day, 1-month, and 3-month
intervals.
For each patient the study will normally take about 7 months.
Both lenses included in this study are approved products and will be used
according to their directions for use.
The purpose of this study design is to compare clinical outcomes, specifically
binocular distance corrected visual acuity at 60 and 40 cm, of patients
bilaterally implanted with the AcrySof® IQ ReSTOR® +2.5 D MIOL to patients
implanted with AcrySof® IQ ReSTOR® +2.5 D MIOL in the dominant eye and AcrySof®
IQ ReSTOR® +3.0 D in their fellow eye. The hypothesis is that the visual
outcomes will be similar between the two groups. Supporting endpoints include
contrast sensitivity, patient reported outcomes, reading speed, and defocus
testing. A descriptive comparison of these endpoints will also be made between
the two arms to show the differences, if any, that a patient may have with
these lens models. This information will allow the surgeon and patient to make
an informed decision about their treatment options after cataract extraction.
Intervention
Eye surgery with removal of the original lens and replacement by an intraocular
lens.
Study burden and risks
The patients will be asked to visit the hospital 7 times in 7 months. Each
visit will take in between 20 minutes and 3 hours. Exceptionally a visit can
take longer. None of the tests are experimental.
There some risks associated with routine cataract surgery. These risks include
bleeding, infection, inflammation, detachment of the retina, increased eye
pressure, and swelling under the retina. There is a small chance that vision
could actually be made worse by the surgical procedure. If the lens is not in
the correct position, the vision may also be affected and the normal flow of
fluid within the eye may be blocked. The patient may require additional surgery
to treat these side effects and improve surgery results.
In addition to the risks associated with routine cataract surgery, the patient
may be more likely to experience visual symptoms such as glare, haziness, halos
around lights, double vision, colour distortions, straight lines or flat
surfaces that appear curved, distorted vision, blurred vision, and queasiness
to thestomach related to the visual symptoms when implanted with the AcrySof®
IQ ReSTOR® +2.5 D or +3.0 D Multifocal IOL.
Multifocal lenses are significantly different than standard monofocal lenses.
Although the multifocal lens is designed to provide near and intermediate
vision in addition to distance vision, it is possible that the patient's near
vision may not be as clear or as sharp in low light as with a monofocal lens
implant when used with glasses. Even with a multifocal lens, the patient may
also need to wear reading glasses to see up close under dim lighting conditions.
The potential vision problems listed above may trouble the patient enough to
require removal of the intraocular lens that was implanted. If there is a
reduction in the vision (near or far) or if the patient has visual symptoms
that cannot be tolerated, the doctor may need to perform a second surgery to
reposition, remove or replace the intraocular lens.
During the study, at different visits, the patient may have eye drops used for
pupil dilation which may cause temporary sensitivity to light and blurred
vision. Sunglasses should be worn in bright light. Driving a car or performing
any hazardous activity should not be done until the effects of the medication
are gone and normal vision returns.
Eye pressure may be tested during the study. The eye pressure test involves
the placement of eye drops containing a small amount of a numbing drop into the
eye. It is important that the patient does not rub your eyes for at least
fifteen (15) minutes after the drops are put in the eye, since small particles
or dust in the eye might scratch the cornea and the numbing drop would make the
patient temporarily unable to feel the pain. Minor scratching of the corneal
surface may rarely occur when the pressure in the eye is measured.
In addition, there is always the risk that uncommon or previously unknown side
effects may occur.
Effects of the implantation of an intraocular lens to an unborn baby or
breast-feeding infant are unknown; however intraocular lenses are commonly used
during pregnancy.
Rijksweg 14
Puurs 2870
NL
Rijksweg 14
Puurs 2870
NL
Listed location countries
Age
Inclusion criteria
1.are adult patients 21 years of age or older at the time of surgery, of either gender or any race;
2.are willing and able to understand and sign an informed consent;
3.are willing and able to attend postoperative examinations per protocol schedule;
4.require cataract extraction followed by posterior IOL implantation used as an on-label procedure in both eyes;
5.be willing to have second eye surgery within 45 days of first eye surgery;
6.are free of severe disease(s)/condition(s) listed in the *Warnings* and *Precautions* section of the AcrySof® IQ ReSTOR® +2.5 D and AcrySof® IQ ReSTOR® +3.0 D MIOL package inserts;
7.are expected to have postoperative astigmatism < 1.0 D in both eyes, measured by keratometry.
Exclusion criteria
1.Refractive lens exchange (CDVA should be worse than 20/20);
2.Significant irregular corneal astigmatism as demonstrated by corneal topography;
3.Patients diagnosed with severe degenerative visual disorders (e.g. macular degeneration or other retinal disorders);
4.Previous corneal surgery;
5.Amblyopia;
6.Planned multiple procedures, including LRI, LASIK, etc. during surgery or the course of this study;
7.Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy);
8.History of corneal disease (e.g., herpes simplex, herpes zoster, etc.);
9.Severe diabetic retinopathy;
10.History of retinal detachment;
11.Patients who have severe conditions of acute or chronic diseases or illnesses that, per investigator*s clinical judgment, would increase the operative risk or confound the results of this investigation;
12.Any patient currently participating in another drug or device study;
13.Pregnant or planning pregnancy during course of study.
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 |
|---|---|
| ClinicalTrials.gov | NCT01684007 |
| CCMO | NL41699.068.12 |