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

This study has been completed.
Sponsor:
Collaborator:
Department of ophthalmology, General Hospital Linz
Information provided by:
General Hospital Linz
ClinicalTrials.gov Identifier:
NCT01244373
First received: November 18, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  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 ] [ Designated as safety issue: No ]
    The best-corrected visual acuity is assessed with glasses after cataract operation


Secondary Outcome Measures:
  • Posterior capsule opacification [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 18, 2010
Last Updated: November 18, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

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

ClinicalTrials.gov processed this record on April 15, 2014