Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification
|ClinicalTrials.gov Identifier: NCT00428363|
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : January 30, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract Pseudophakia||Device: Cataract surgery with implantation of an intraocular lens||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||June 2001|
|Estimated Study Completion Date :||March 2006|
- amount of posterior capsule opacification (objective and subjective score 0-10)
- visual acuity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428363
|Dept. of Ophthalmology, Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Rupert Menapace, MD||Medical University of Vienna|
|Principal Investigator:||Oliver Findl, MD||Medical University of Vienna|