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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 30, 2014