Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses (Acryvivi)
Status
Conditions
Treatments
Details and patient eligibility
About
On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.
A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- Age 50 and older
- Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion criteria
- Preceding intraocular surgery or ocular trauma
- Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
- Laser treatment
- Uncontrolled systemic or ocular disease
- Infectious disease
- Pregnancy/Nursing
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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