Cataract Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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