Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00428363

Purpose

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	Intervention	Phase
Cataract Pseudophakia	Device: Cataract surgery with implantation of an intraocular lens	Phase IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

amount of posterior capsule opacification (objective and subjective score 0-10)

Secondary Outcome Measures:

visual acuity

Estimated Enrollment:	52
Study Start Date:	June 2001
Estimated Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

bilateral, age related cataract

Exclusion Criteria:

history of other ocular disease or intraocular surgery
diabetes requiring medical control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428363

Locations

Austria
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

More Information

Homepage of the Vienna IOL Study Group (Dept. of Ophthalmology, Medical University of Vienna) This link exits the ClinicalTrials.gov site

Publications of Results:

Buehl W, Menapace R, Sacu S, Kriechbaum K, Koeppl C, Wirtitsch M, Georgopoulos M, Findl O. Effect of a silicone intraocular lens with a sharp posterior optic edge on posterior capsule opacification. J Cataract Refract Surg. 2004 Aug;30(8):1661-7.

Other 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.

Study ID Numbers:	EK2512001
Study First Received:	January 29, 2007
Last Updated:	January 29, 2007
ClinicalTrials.gov Identifier:	NCT00428363
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:

posterior capsule opacification
PCO
after cataract

intraocular lens
optic edge design
sharp optic edge

Study placed in the following topic categories:

Signs and Symptoms
Pseudophakia
Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009