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

This study has been completed.
Sponsor:
Information provided by:
Hospital Hietzing
ClinicalTrials.gov Identifier:
NCT00673803
First received: May 6, 2008
Last updated: August 16, 2010
Last verified: December 2008
History of Changes
  Purpose

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 Intervention Phase
Cataract
 Procedure: cataract surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Hospital Hietzing:

Primary Outcome Measures:
  • PCO rate [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: June 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Matthias Wirtitsch MD, Hietzing Hospital, Vienna, Austria
ClinicalTrials.gov Identifier: NCT00673803     History of Changes
Other Study ID Numbers: preloaded 2008
Study First Received: May 6, 2008
Last Updated: August 16, 2010
Health Authority: Austria: Ethikkommission

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

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

ClinicalTrials.gov processed this record on May 16, 2013