Effect of Optic Edge Design in a Silicone Intraocular Len... | NCT00428363

Studies
Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification

NCT00428363

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jan 30, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Cataract
Pseudophakia

Interventions

Cataract surgery with implantation of an intraocular lens

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

Jan 2007

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

Jun 2001

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Jan 29, 2007

First Submission Date that Met QC Criteria

Jan 29, 2007

First Posted Date

Jan 30, 2007Estimated

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

Jan 29, 2007

Last Update Posted Date

Jan 30, 2007Estimated

Description Module

Brief Summary

Purpose: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Clariflex silicone intraocular lens (IOL) with that of the double-round edge design of the SI40 (Phacoflex) silicone IOL over a period of 3 years.

Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.

Methods: Fifty-two patients with bilateral age-related cataract (104 eyes) were included in this randomized, prospective, bilateral, patient- and examiner-masked clinical trial with intra-individual comparison. Each study patient had cataract surgery in both eyes and received an SI40 IOL (anterior and posterior round optic edges) in one eye and a Clariflex IOL with OptiEdge (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at one week, one month, six months, one, two, and three years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slit-lamp and objectively using automated image analysis software (AQUA) one, two, and three years after surgery.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Cataract surgery with implantation of an intraocular lens	Device

Measure	Description	Time Frame
amount of posterior capsule opacification (objective and subjective score 0-10)

Measure	Description	Time Frame
visual acuity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

bilateral, age related cataract

Exclusion Criteria:

history of other ocular disease or intraocular surgery
diabetes requiring medical control

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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
Rupert Menapace, MD	Medical University of Vienna	Principal Investigator
Oliver Findl, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Ophthalmology, Medical University of Vienna		Vienna	State of Vienna	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12106717	Background	Buehl W, Findl O, Menapace R, Rainer G, Sacu S, Kiss B, Petternel V, Georgopoulos M. Effect of an acrylic intraocular lens with a sharp posterior optic edge on posterior capsule opacification. J Cataract Refract Surg. 2002 Jul;28(7):1105-11. doi: 10.1016/s0886-3350(02)01371-8.
15975461	Background	Buehl W, Findl O, Menapace R, Sacu S, Kriechbaum K, Koeppl C, Wirtitsch M. Long-term effect of optic edge design in an acrylic intraocular lens on posterior capsule opacification. J Cataract Refract Surg. 2005 May;31(5):954-61. doi: 10.1016/j.jcrs.2004.09.053.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

ID	Term
D002386	Cataract
D019591	Pseudophakia
D058442	Capsule Opacification