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Influence of Two Different Preloaded Intraocular Lens (IOLs) on Posterior Capsule Opacification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00673803
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Hospital Hietzing

Brief Summary:

Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits migration of lens epithelial cells in between posterior capsule and optic of the IOL and therefore reduces the rate of posterior capsule opacification (PCO). In present time most IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production different IOLs have different rates of PCO.

Progression in cataract surgery technique allow phacoemulsification through micro-incisions. Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.

This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp posterior optic edge on the rate of PCO after implantation through a micro-incision. The results will be compared intraindividually.


Condition or disease Intervention/treatment Phase
Cataract Procedure: cataract surgery Phase 4

Detailed Description:

prospective, randomized, bilateral study with intraindividual comparison, implantation of a Polylens Y10 IOL in one eye and implantation of a Polylens Y30 in the contralateral eye.

PCO rate will be detected at 1 year and 2 years.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Two Sharp-edged Hydrophobic Acrylic Micro-incision-IOLs on Posterior Capsule Opacification. A Randomized, Double-masked Study With Intraindividual Comparison.
Study Start Date : December 2008
Primary Completion Date : July 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
A
cataract surgery, implantation of a Polylens Y10
Procedure: cataract surgery
cataract surgery with implantation of an IOL
Other Names:
  • Polylens Y30 IOL, Polytech, Germany
  • Polylens Y10 IOL, Polytech, Germany
B
cataract surgery, implantation of a Polylens Y30
Procedure: cataract surgery
cataract surgery with implantation of an IOL
Other Names:
  • Polylens Y30 IOL, Polytech, Germany
  • Polylens Y10 IOL, Polytech, Germany



Primary Outcome Measures :
  1. PCO rate [ Time Frame: 2 years after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bilateral age-related cataract
  • age 55 to 80 years
  • expected postoperative visual acuity of at least 0.5

Exclusion Criteria:

  • amblyopia
  • corneal scars
  • diabetes
  • pseudoexfoliation-syndrome
  • earlier ocular surgeries or laser treatments
  • intraocular tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673803


Locations
Austria
Department of Ophthalmology, Hietzing Hospital
Vienna, Austria, 1130
Sponsors and Collaborators
Hospital Hietzing
Investigators
Study Chair: Nadja Karnik, MD Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

Responsible Party: Matthias Wirtitsch MD, Hietzing Hospital, Vienna, Austria
ClinicalTrials.gov Identifier: NCT00673803     History of Changes
Other Study ID Numbers: preloaded 2008
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: December 2008

Keywords provided by Hospital Hietzing:
posterior capsule opacification
micro incision
sharp optic edge

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases