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

NCT ID: NCT00428363

Last Updated: 2007-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2006-03-31

Brief Summary

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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 Description

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Conditions

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Cataract Pseudophakia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Cataract surgery with implantation of an intraocular lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* bilateral, age related cataract

Exclusion Criteria

* history of other ocular disease or intraocular surgery
* diabetes requiring medical control
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Principal Investigators

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Rupert Menapace, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Oliver Findl, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Dept. of Ophthalmology, Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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. doi: 10.1016/j.jcrs.2004.09.053.

Reference Type BACKGROUND
PMID: 15975461 (View on PubMed)

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. doi: 10.1016/j.jcrs.2004.02.051.

Reference Type RESULT
PMID: 15313288 (View on PubMed)

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. doi: 10.1016/s0886-3350(02)01371-8.

Reference Type BACKGROUND
PMID: 12106717 (View on PubMed)

Other Identifiers

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EK2512001

Identifier Type: -

Identifier Source: org_study_id