Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/16/2018 |
| Start Date: | February 2006 |
| End Date: | August 2007 |
Contralateral Eye Comparison of Visual Outcomes and Patient Satisfaction After Routine Phacoemulsification and Implantation of ReSTOR and ReZoom IOLs
Cataract is prevalent throughout the world and IOLs are routinely implanted after the
extraction of the cataractous lens. It is the most frequently performed surgery in the United
States with an estimated 2-3 million procedures performed annually. With the aging population
on the rise, as well as the increasing popularity of refractive intraocular lenses, the
number of intraocular surgeries continues to rise. Over the years, the surgical technique has
evolved from intracapsular extraction to modern phacoemulsification. This development has
helped with the evolution of IOLs as well. The IOLs have advanced extensively: different
materials and designs are available, permitting implantation through smaller, sutureless
incisions. Traditional IOLs are of monofocal design providing vision at one distance,
typically far. Patients implanted with traditional monofocal IOLs usually require glasses for
near distance tasks such as reading. The new multifocal IOLs offer the possibility of seeing
well at more than one distance, without glasses or contacts.
The AcrySof ReSTOR (Alcon Laboratories) uses apodized diffractive technology — a design that
responds to how wide or small the eye's pupil might be — to provide near, intermediate, and
distance vision. Clinical studies used to support the March 2005 FDA approval showed that 80%
of people who received the lens did not use glasses for any activities after their cataract
surgery; 84% who received the lens in both eyes had distance vision of 20/25 or better, with
near vision of 20/32 or better.
ReZoom (Advanced Medical Optics) is a multifocal refractive zonal IOL that distributes light
over five optical zones to provide near, intermediate, and distance vision. The ReZoom is a
second-generation multifocal and was FDA-approved in March 2005. In a European study of 215
patients, 93% of ReZoom recipients reported never or only occasionally needing glasses. The
combined use of multifocal intraocular lenses is often a solution to best meet the patients'
refractive needs. There has been speculation that the implantation of ReSTOR in one eye and
ReZoom lens in the fellow eye can provide patients a larger range of useful vision in the
near range.
The purpose of this study is to evaluate visual outcome and patient satisfaction after
implantation of a diffractive multifocal IOL (ReSTOR) in one eye and a refractive multifocal
IOL (ReZoom) in the fellow eye after routine phacoemulsification and compare it to a control
group of patients implanted bilaterally with ReSTOR with both eyes targeted for 0 to ±0.25 D,
and to a group of patients implanted bilaterally with ReSTOR with the non-dominant eye
targeted for +1.00 D and the dominant eye targeted for 0 to +0.25 D.
extraction of the cataractous lens. It is the most frequently performed surgery in the United
States with an estimated 2-3 million procedures performed annually. With the aging population
on the rise, as well as the increasing popularity of refractive intraocular lenses, the
number of intraocular surgeries continues to rise. Over the years, the surgical technique has
evolved from intracapsular extraction to modern phacoemulsification. This development has
helped with the evolution of IOLs as well. The IOLs have advanced extensively: different
materials and designs are available, permitting implantation through smaller, sutureless
incisions. Traditional IOLs are of monofocal design providing vision at one distance,
typically far. Patients implanted with traditional monofocal IOLs usually require glasses for
near distance tasks such as reading. The new multifocal IOLs offer the possibility of seeing
well at more than one distance, without glasses or contacts.
The AcrySof ReSTOR (Alcon Laboratories) uses apodized diffractive technology — a design that
responds to how wide or small the eye's pupil might be — to provide near, intermediate, and
distance vision. Clinical studies used to support the March 2005 FDA approval showed that 80%
of people who received the lens did not use glasses for any activities after their cataract
surgery; 84% who received the lens in both eyes had distance vision of 20/25 or better, with
near vision of 20/32 or better.
ReZoom (Advanced Medical Optics) is a multifocal refractive zonal IOL that distributes light
over five optical zones to provide near, intermediate, and distance vision. The ReZoom is a
second-generation multifocal and was FDA-approved in March 2005. In a European study of 215
patients, 93% of ReZoom recipients reported never or only occasionally needing glasses. The
combined use of multifocal intraocular lenses is often a solution to best meet the patients'
refractive needs. There has been speculation that the implantation of ReSTOR in one eye and
ReZoom lens in the fellow eye can provide patients a larger range of useful vision in the
near range.
The purpose of this study is to evaluate visual outcome and patient satisfaction after
implantation of a diffractive multifocal IOL (ReSTOR) in one eye and a refractive multifocal
IOL (ReZoom) in the fellow eye after routine phacoemulsification and compare it to a control
group of patients implanted bilaterally with ReSTOR with both eyes targeted for 0 to ±0.25 D,
and to a group of patients implanted bilaterally with ReSTOR with the non-dominant eye
targeted for +1.00 D and the dominant eye targeted for 0 to +0.25 D.
Inclusion Criteria:
- Subject must have an age-related cataract in both eyes.
- 18 years of age or older.
- Patient must desire cataract extraction.
- Expected maximum of 4 weeks and minimum of 1 week interval between first and second
eye surgeries.
- Willing and able to comply with scheduled visits and other study procedures.
Exclusion Criteria:
- Preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic
retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or
iris atrophy, uveitis, history of iritis, iris neovascularization, medically
uncontrolled glaucoma, microphtalmus or macrophtalmus, optic nerve atrophy, macular
degeneration (with anticipated best postoperative visual acuity less than 20/30),
advanced glaucomatous damage, etc.
- Keratometric astigmatism exceeding 2.0 diopters.
- Planned postoperative refraction for mono-vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- Pregnant or nursing mothers and females of childbearing potential not practicing a
reliable and medically acceptable method of birth control.
- Any clinically significant, serious or severe medical or psychiatric condition that
may increase the risk associated with study participation or study device implantation
or may interfere with the interpretation of study results.
- Participation in (or current participation) any investigational drug or device trial
within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser
surgery within one month in the operated eye.
- Other ocular surgery at the time of the cataract extraction.
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