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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00428363

First Posted: January 30, 2007

Last Update Posted: January 30, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Medical University of Vienna

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Cataract

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:

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

Publications:

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.

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.


ClinicalTrials.gov Identifier:	NCT00428363 History of Changes
Other Study ID Numbers:	EK2512001
First Submitted:	January 29, 2007
First Posted:	January 30, 2007
Last Update Posted:	January 30, 2007
Last Verified:	January 2007

Keywords provided by Medical University of Vienna:


posterior capsule opacification PCO after cataract	intraocular lens optic edge design sharp optic edge

Additional relevant MeSH terms:


Cataract Capsule Opacification Pseudophakia	Lens Diseases Eye Diseases Signs and Symptoms

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