Comparison of Ultrasonic Pachymetry With Orbscan in Corne... | NCT00439114

Studies
Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

NCT00439114

Sponsor

Baskent University

Status

Completed

Last Update Posted

Feb 23, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Corneal Opacity

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Feb 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 2005

Primary Completion Date

Not provided

Completion Date

Jun 2006

First Submitted Date

Feb 21, 2007

First Submission Date that Met QC Criteria

Feb 21, 2007

First Posted Date

Feb 23, 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

Feb 21, 2007

Last Update Posted Date

Feb 23, 2007Estimated

Description Module

Brief Summary

This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis.

Detailed Description

We planned this study to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. In this institutional based, prospective, controlled clinical trial subjects with corneal haze not related to surgery are included. Normal eyes are used as control group to calculate the customized acoustic factor. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained by one technician each masked to the other measurement. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis. According to the results of the study, we will determine which method is accurate in subjects with corneal haze.

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with significant corneal haze on slit-lamp are included in the study group. 50 eyes of 50 age-matched patients with normal eye and clear cornea are included in the control group. Only one eye of each subject is included.

Exclusion Criteria:

Exclusion criteria to participate in the study are previous ocular surgery, history of contact lens use, glaucoma, and topical ocular medication use, excluding artificial tears.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

71 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
Rana Altan-Yaycioglu, M.D.	Baskent University, Faculty of Medicine, Department of Ophthalmology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baskent University, Faculty of Medicine, Adana Hospital		Adana		01250	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11821206	Background	Boscia F, La Tegola MG, Alessio G, Sborgia C. Accuracy of Orbscan optical pachymetry in corneas with haze. J Cataract Refract Surg. 2002 Feb;28(2):253-8. doi: 10.1016/s0886-3350(01)01162-2.
11377895	Background	Iskander NG, Anderson Penno E, Peters NT, Gimbel HV, Ferensowicz M. Accuracy of Orbscan pachymetry measurements and DHG ultrasound pachymetry in primary laser in situ keratomileusis and LASIK enhancement procedures. J Cataract Refract Surg. 2001 May;27(5):681-5. doi: 10.1016/s0886-3350(01)00820-3.

ID	Term
D003318	Corneal Opacity
D007634	Keratitis
D014141	Trachoma

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D003234	Conjunctivitis, Bacterial
D015818	Eye Infections, Bacterial