Age Related Cataracts
Conditions
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.
Interventions
DEVICEAlcon SN60WF
Implantation of an intraocular lens Alcon SN60WF
DEVICEHoya Vivinex
Implantation of an intraocular lens Hoya Vivinex
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCO score | 3 years | subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 3 years | UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity) |
| Fibrosis | 3 years | grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis) |
| Subjective glistening score | 3 years | neg, \<10, 10-20, 20-30, 30-40, \>40 uniform or localized |
| YAG capsulotomy rate | 3 years | described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no |
Outcome results
None listed