Clinical Trial: Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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.

Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: amount of posterior capsule opacification (objective and subjective score 0-10)

Original Primary Outcome: Same as current

Current Secondary Outcome: visual acuity

Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: January 29, 2007
Date Started: June 2001
Date Completion: March 2006
Last Updated: January 29, 2007
Last Verified: January 2007