Cataract, Pseudophakia
Conditions
Keywords
posterior capsule opacification, PCO, after cataract, intraocular lens, optic edge design, sharp optic edge
Brief summary
Purpose: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Clariflex silicone intraocular lens (IOL) with that of the double-round edge design of the SI40 (Phacoflex) silicone IOL over a period of 3 years. Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Methods: Fifty-two patients with bilateral age-related cataract (104 eyes) were included in this randomized, prospective, bilateral, patient- and examiner-masked clinical trial with intra-individual comparison. Each study patient had cataract surgery in both eyes and received an SI40 IOL (anterior and posterior round optic edges) in one eye and a Clariflex IOL with OptiEdge (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at one week, one month, six months, one, two, and three years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slit-lamp and objectively using automated image analysis software (AQUA) one, two, and three years after surgery.
Interventions
DEVICECataract surgery with implantation of an intraocular lens
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bilateral, age related cataract
Exclusion criteria
* history of other ocular disease or intraocular surgery * diabetes requiring medical control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| amount of posterior capsule opacification (objective and subjective score 0-10) | — |
Secondary
| Measure | Time frame |
|---|---|
| visual acuity | — |
Countries
Austria
Outcome results
None listed