A Prospective Observational Case Series of a Four-ring-ha... | NCT01244373

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

NCT01244373

Sponsor

General Hospital Linz

Status

Completed

Last Update Posted

Nov 19, 2010Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Cataract

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Nov 18, 2010

First Submission Date that Met QC Criteria

Nov 18, 2010

First Posted Date

Nov 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2010

Last Update Posted Date

Nov 19, 2010Estimated

Name	Class
Department of ophthalmology, General Hospital Linz	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
Patients with senile cataract		Patients with senile cataract

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced age-related cataract and indication for phacoemuslification of the lens with following implantation of an intraocular lens (posterior chamber)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of ophthalmology, General Hospital Linz		Linz	Upper Austria	4021	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19756637	Background	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.
20362866	Background	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.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases