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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01244373

Acronym

Qu01

Enrollment

Registered

2010-11-19

Start date

2008-05-31

Completion date

2009-08-31

Last updated

2010-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Best-corrected visual acuity, posterior capsule opacification, QUATRIX® Aspheric Evolutive pre-loaded

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Best-corrected visual acuity (BCVA)	Six months	The best-corrected visual acuity is assessed with glasses after cataract operation

Secondary

Measure	Time frame	Description
Posterior capsule opacification	Six months	The posterior capsule opacification is assessed by slit lamp examination and subjective grading

Countries

Austria

Outcome results