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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00428363
Collaborator
(none)
52
Enrollment
1
Location
57
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Cataract surgery with implantation of an intraocular lens
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Study Start Date :
Jun 1, 2001
Study Completion Date :
Mar 1, 2006

Outcome Measures

Primary Outcome Measures

  1. amount of posterior capsule opacification (objective and subjective score 0-10) []

Secondary Outcome Measures

  1. visual acuity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • bilateral, age related cataract
Exclusion Criteria:
  • history of other ocular disease or intraocular surgery

  • diabetes requiring medical control

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Dept. of Ophthalmology, Medical University of ViennaViennaAustria1090

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00428363
Other Study ID Numbers:
  • EK2512001
First Posted:
Jan 30, 2007
Last Update Posted:
Jan 30, 2007
Last Verified:
Jan 1, 2007

Study Results

No Results Posted as of Jan 30, 2007