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

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ClinicalTrials.gov Identifier: NCT01244373
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
Sponsor:
Collaborator:
Department of ophthalmology, General Hospital Linz
Information provided by:
General Hospital Linz

Brief Summary:
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 or disease
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.

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Case Series of the Implantation of Intraocular Lens "QUATRIX® Aspheric Evolutive Pre-loaded".
Study Start Date : May 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Group/Cohort
Patients with senile cataract
Patients with senile cataract



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


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



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

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

Publications:
Responsible Party: PD Dr. Siegfried G. Priglinger
ClinicalTrials.gov Identifier: NCT01244373     History of Changes
Other Study ID Numbers: Quatrix01
First Posted: November 19, 2010    Key Record Dates
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