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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00428363
First received: January 29, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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

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

Publications:

ClinicalTrials.gov Identifier: NCT00428363     History of Changes
Other Study ID Numbers: EK2512001
Study First Received: January 29, 2007
Last Updated: January 29, 2007
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

Additional relevant MeSH terms:
Pseudophakia
Cataract
Capsule Opacification
 Signs and Symptoms
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013