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OpenTrials
Completed

NCT Number: NCT01244373

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of ophthalmology, General Hospital Linz

Linz, Upper Austria, 4021, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Best-corrected visual acuity (BCVA)

    Time frame: Six months

    The best-corrected visual acuity is assessed with glasses after cataract operation

Secondary outcomes

  1. Posterior capsule opacification

    Time frame: Six months

    The posterior capsule opacification is assessed by slit lamp examination and subjective grading

Sponsors and collaborators

Lead sponsor

General Hospital Linz

Other

Collaborators

  • Department of ophthalmology, General Hospital Linz

Registry information

Official study title

Observational Case Series of the Implantation of Intraocular Lens "QUATRIX® Aspheric Evolutive Pre-loaded".

Acronym: Qu01

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2010
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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