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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428363
• Other study ID #: EK2512001
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2007
• Last updated: January 29, 2007
• Start date: June 2001
• Est. completion date: March 2006

Study information

• Verified date: January 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• bilateral, age related cataract

Exclusion Criteria:

• history of other ocular disease or intraocular surgery

• diabetes requiring medical control

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Pseudophakia

Intervention

Device:
• Cataract surgery with implantation of an intraocular lens

Locations

Country	Name	City	State
Austria	Dept. of Ophthalmology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of posterior capsule opacification (objective and subjective score 0-10)
Secondary	visual acuity

External Links

•   Homepage of the Vienna IOL Study Group (Dept. of Ophthalmology, Medical University of Vienna)