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

NCT00428363 | Completed Phase 4

• 1 other identifier: EK2512001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Pseudophakia

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• visual acuity

Interventions

Cataract surgery with implantation of an intraocular lens DEVICE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral, age related cataract

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Dept. of Ophthalmology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

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

  PMID: 12106717 BACKGROUND

• 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.

  PMID: 15975461 BACKGROUND

• 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.

  PMID: 15313288 RESULT

MeSH Terms

Conditions

Cataract; Pseudophakia; Capsule Opacification

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Rupert Menapace, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Oliver Findl, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: June 1, 2001
• Study Completion: March 1, 2006
• Last Updated: January 30, 2007

Record last verified: 2007-01

Locations

AU (1)