Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- amount of posterior capsule opacification (objective and subjective score 0-10) []
Secondary Outcome Measures
- visual acuity []
Eligibility Criteria
Criteria
Inclusion Criteria:
- bilateral, age related cataract
Exclusion Criteria:
-
history of other ocular disease or intraocular surgery
-
diabetes requiring medical control
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Dept. of Ophthalmology, Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Rupert Menapace, MD, Medical University of Vienna
- Principal Investigator: Oliver Findl, MD, Medical University of Vienna
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Buehl W, Findl O, Menapace R, Rainer G, Sacu S, Kiss B, Petternel V, Georgopoulos M. Effect of an acrylic intraocular lens with a sharp posterior optic edge on posterior capsule opacification. J Cataract Refract Surg. 2002 Jul;28(7):1105-11.
- Buehl W, Findl O, Menapace R, Sacu S, Kriechbaum K, Koeppl C, Wirtitsch M. Long-term effect of optic edge design in an acrylic intraocular lens on posterior capsule opacification. J Cataract Refract Surg. 2005 May;31(5):954-61.
- EK2512001