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A Prospective Observational Case Series of a Four-ring-haptic Acrylic One-piece IOL (Qu01)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244373
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
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.
Collaborator:
Department of ophthalmology, General Hospital Linz
Information provided by:
General Hospital Linz
  Purpose
To describe biocompatibility, postoperative results and complications after implantation of the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.

Condition
Cataract

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Case Series of the Implantation of Intraocular Lens "QUATRIX® Aspheric Evolutive Pre-loaded".

Resource links provided by NLM:


Further study details as provided by General Hospital Linz:

Primary Outcome Measures:
  • Best-corrected visual acuity (BCVA) [ Time Frame: Six months ]
    The best-corrected visual acuity is assessed with glasses after cataract operation


Secondary Outcome Measures:
  • Posterior capsule opacification [ Time Frame: Six months ]
    The posterior capsule opacification is assessed by slit lamp examination and subjective grading


Enrollment: 9
Study Start Date: May 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with senile cataract
Patients with senile cataract

Detailed Description:
In this prospective case series the Corneal Quatrix Evolutive IOL was implanted in 14 eyes of nine patients with senile cortico-nuclear cataract. A standardized surgical technique and post-operative regimen were applied. Six months postoperatively best corrected visual acuity (BCVA), refraction and complications (especially) posterior capsule opacification (PCO) were analysed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced age-related cataract and indication for phacoemuslification of the lens with following implantation of an intraocular lens (posterior chamber)
Criteria

Inclusion Criteria:

Patients with senile cortico-nuclear cataracts without previous intraocular surgery

Exclusion Criteria:

  • Dilated pupil size of < 6 mm
  • long-term anti-inflammatory treatment
  • previous history of intraocular surgery
  • previous history of corneal endothelial damage
  • previous history of ocular trauma
  • traumatic cataract
  • history of uveitis
  • diabetic retinopathy
  • advanced macular degeneration
  Contacts and Locations
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): NCT01244373


Locations
Austria
Department of ophthalmology, General Hospital Linz
Linz, Upper Austria, Austria, 4021
Sponsors and Collaborators
General Hospital Linz
Department of ophthalmology, General Hospital Linz
  More Information

Publications:
Responsible Party: PD Dr. Siegfried G. Priglinger
ClinicalTrials.gov Identifier: NCT01244373     History of Changes
Other Study ID Numbers: Quatrix01
First Submitted: November 18, 2010
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by General Hospital Linz:
Best-corrected visual acuity
posterior capsule opacification
QUATRIX® Aspheric Evolutive pre-loaded

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases