Light Filters in Intraocular Lenses (IOLs) and Its Influe... | NCT00612729

Studies
Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.

NCT00612729

Sponsor

Hospital Hietzing

Status

Completed

Last Update Posted

Aug 17, 2010Estimated

Enrollment

32Actual

Phase

Phase 4

Conditions

Cataract

Interventions

Polylens Y30 intraocular lens
Orange Series Model PC 440 Y 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

Dec 2008

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

Nov 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jan 29, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Feb 12, 2008Estimated

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

Aug 16, 2010

Last Update Posted Date

Aug 17, 2010Estimated

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

Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of two light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.

Detailed Description

Prospective, randomized, double-masked study with intraindividual comparison. Implantation of a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.

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

32Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polylens Y30 intraocular lens	Procedure	cataract surgery
Orange Series Model PC 440 Y intraocular lens	Procedure	cataract surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
contrast acuity		3 month after surgery

Secondary Outcomes

Measure	Description	Time Frame
visual acuity and color vision		3 month after surgery
colour perception		3 month after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

bilateral age-related cataract
age 55 to 80 years
expected postoperative visual acuity of at least 1.0

Exclusion Criteria:

amblyopia
corneal scars
diabetes
arterial hypertonia
pseudoexfoliation-syndrome
earlier ocular surgeries or laser treatments
intraocular tumors
color abnormalities
expected postoperative visual acuity lower 1.0

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias G Wirtitsch, MD	Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria	Principal Investigator
Nadja Karnik, MD	Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Hietzing Hospital		Vienna		1130	Austria

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided