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

Cataract Clinical Trial

— Qu01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244373
• Other study ID #: Quatrix01
• Status: Completed
• Phase: N/A
• First received: November 18, 2010
• Last updated: November 18, 2010
• Start date: May 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2010
• Source: General Hospital Linz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
Austria	Department of ophthalmology, General Hospital Linz	Linz	Upper Austria

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital Linz	Department of ophthalmology, General Hospital Linz

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Kramer S, Schröder AC, Brückner K, Jonescu-Cuypers C, Seitz B. [Subluxation of hydrophilic acrylate intraocular lenses due to massive capsular fibrosis]. Ophthalmologe. 2010 May;107(5):460-4. doi: 10.1007/s00347-009-2025-y. German. — View Citation

Michael K, O'Colmain U, Vallance JH, Cormack TG. Capsule contraction syndrome with haptic deformation and flexion. J Cataract Refract Surg. 2010 Apr;36(4):686-9. doi: 10.1016/j.jcrs.2009.09.042. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity (BCVA)	The best-corrected visual acuity is assessed with glasses after cataract operation	Six months	No
Secondary	Posterior capsule opacification	The posterior capsule opacification is assessed by slit lamp examination and subjective grading	Six months	No