Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs. Acrysof SN60WF
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 80
- Primary Endpoint
- PCO score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Alcon SN60WF
Implantation of an intraocular lens Alcon SN60WF
Intervention: Alcon SN60WF (Device)
Hoya Vivinex
Implantation of an intraocular lens Hoya Vivinex
Intervention: Hoya Vivinex (Device)
Outcomes
Primary Outcomes
PCO score
Time Frame: 3 years
subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)
Secondary Outcomes
- Visual Acuity(3 years)
- Fibrosis(3 years)
- Subjective glistening score(3 years)
- YAG capsulotomy rate(3 years)
Investigators
Rupert Menapace
Clinical Professor
Medical University of Vienna