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

Sponsor
Hospital Hietzing (Other)
Overall Status
Completed
CT.gov ID
NCT00673803
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
18
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Dec 1, 2008
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: 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

    		•
    Other: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PCO rate [2 years after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00673803
    Other Study ID Numbers:
    • preloaded 2008
    First Posted:
    May 7, 2008
    Last Update Posted:
    Aug 17, 2010
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    posterior capsule opacification
    micro incision
    sharp optic edge
    Additional relevant MeSH terms:
    Cataract
    Capsule Opacification

    Study Results

    No Results Posted as of Aug 17, 2010