Acrylate Intraocular Lenses in Cataract Surgery of Uveiti... | NCT00403832

Studies
Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients

NCT00403832

Sponsor

St. Franziskus Hospital

Status

Completed

Last Update Posted

Jul 28, 2010Estimated

Enrollment

Phase

Not Applicable

Conditions

Uveitis
Cataract

Interventions

intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)

Countries

Germany

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

Aug 2009

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

Aug 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007

First Submitted Date

Nov 24, 2006

First Submission Date that Met QC Criteria

Nov 24, 2006

First Posted Date

Nov 27, 2006Estimated

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

Jul 26, 2010

Last Update Posted Date

Jul 28, 2010Estimated

Description Module

Brief Summary

Cataract is a common complication in uveitis patients. Cataract operations with intraocular lens implantation are difficult in these patients because of complication due to the biocompatibility of the intraocular lens. In this study, uveal and capsular biocompatibility of two widely used acrylate intraocular lenses are compared.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity
cell deposits on anterior IOL surface
posterior capsular opacification

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non infectious uveitis
no active inflammation
significant visual disturbance related to lens opacification

Exclusion Criteria:

vitreous opacification
ocular hypertension/glaucoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnd Heiligenhaus, Md Phd	Department of Ophthalmology at St.-FranziskusHospital Münster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology at St.-Franziskus Hospital		Münster		48145	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20082200	Derived	Roesel M, Heinz C, Koch JM, Heiligenhaus A. Comparison of orbital floor triamcinolone acetonide and oral prednisolone for cataract surgery management in patients with non-infectious uveitis. Graefes Arch Clin Exp Ophthalmol. 2010 May;248(5):715-20. doi: 10.1007/s00417-009-1269-1. Epub 2010 Jan 16.

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases
D007905	Lens Diseases

ID	Term
D014605	Uveitis
D002386	Cataract