NCT01244373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

1.3 years

First QC Date

November 18, 2010

Last Update Submit

November 18, 2010

Conditions

Cataract

Keywords

Best-corrected visual acuityposterior capsule opacificationQUATRIX® Aspheric Evolutive pre-loaded

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity (BCVA)

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

    Six months

Secondary Outcomes (1)

  • Posterior capsule opacification

    Six months

Study Arms (1)

Patients with senile cataract

Patients with senile cataract

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Patients with senile cortico-nuclear cataracts without previous intraocular surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ophthalmology, General Hospital Linz

Linz, Upper Austria, 4021, Austria

Location

Related Publications (2)

  • Kramer S, Schroder AC, Bruckner 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.

    PMID: 19756637BACKGROUND

  • 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.

    PMID: 20362866BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

May 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

AU(1)