Evaluation Study for a Non-Contact Biometer | NCT00494390

Studies
Evaluation Study for a Non-Contact Biometer

NCT00494390

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Mar 19, 2008Estimated

Enrollment

95Estimated

Phase

Not provided

Conditions

Cataract
Pseudophakia
Myopia
Hyperopia
Aphakia

Interventions

Not provided

Countries

Switzerland

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

ID	Type	Description	Link
Insel 1351

Status Module

Record Verification Date

Jul 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

Jul 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Not provided

First Submitted Date

Jun 27, 2007

First Submission Date that Met QC Criteria

Jun 27, 2007

First Posted Date

Jun 29, 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

Mar 18, 2008

Last Update Posted Date

Mar 19, 2008Estimated

Name	Class
Haag-Streit AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard.

Detailed Description

The features of a not yet commercial available new biometer will be compared to available contact and non contact biometers in different patient groups.

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

95Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 year or older
Normal eye
Cataract
Corneal abnormality (scar, opacity, transplant)
refractive corneal surgery
Pseudophakia
Aphakia
Silicon oil
refractive IOL

2.-9. (at least one yes)

Accepts Healthy Volunteers

Yes

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

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Goldblum, MD	www.insel.ch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, University Hospital		Bern		3010	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D019591	Pseudophakia
D009216	Myopia
D006956	Hyperopia
D001035	Aphakia
D003318	Corneal Opacity
D001251	Astigmatism

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided