Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining

Evaluation of Corneal Stability Post-applanation Clinical Trial

Official title:

Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275142
• Other study ID #: 170608-1
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: Comprehensive EyeCare of Central Ohio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at any time during an exam, without affecting other testing. This may improve office-flow and spare patients from returning for another exam for additional testing.

Description:

Four sites will enroll fifteen subjects each. Individual sites will identify their patients using numbers 1-15. The link to their identity will be stored in their records but will not be forwarded to other investigators. Only the originating site will have the identity log linking the participants to the study records. All patients over age 18 in the patient clinic are eligible for inclusion. Staff members and employees may also participate. Following informed consent, each patient will undergo visual acuity testing, keratometry readings by IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare tonometer will be used to check the intraocular pressure (IOP) on one eye only. The investigator will be masked as to which eye will undergo applanation. Immediately following the IOP check, corneal staining, topography and keratometry readings will be repeated. The unchecked eye will serve as a control as there may be mild variations in topography or IOL Master even without applanation. Following the repeated testing, the control eye will also undergo applanation to document IOP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

Exclusion Criteria:

• Under 18 years of age

Related Conditions & MeSH terms

• Evaluation of Corneal Stability Post-applanation

Intervention

Device:
• Icare tonometer
Icare tonometry effects of keratometry readings, topography, and corneal staining to demonstrate that the Icare tonometer does not alter subsequent evaluation or testing. This would allow IOP testing to be performed by technical staff at any time during the examination process without affecting subsequent tests. A total of fifteen patients at each of four sites will be evaluated using Icare tonometers provided by Icare USA. The investigator will be masked as to which eye will undergo Icare tonometry. Both the study eye and the control eye will undergo pre-tonometry and post-tonometry testing; Keratometry readings, IOL master, Topography via Pentacam, and corneal staining with fluorescein using the Oxford scoring scale.

Locations

Country	Name	City	State
United States	Comprehensive EyeCare of Central Ohio	Westerville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Comprehensive EyeCare of Central Ohio	Icare USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of corneal stability post-applanation with the Icare tonometer.	Demonstration that the Icare tonometer does not alter keratometry readings performed by IOL Master, topography performed by Pentacam HR, or corneal staining as evaluated at slit-lamp with fluorescence as compared to the Oxford Grading Scale	30 minutes
Secondary	Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.	Evaluation of average keratometric difference pre and post-tonometry with ICare via Pentacam HR and IOL Master.	10 minutes
Secondary	Total cylinder differences pre and post-tonometry with ICare tonometer.	Total cylinder differences pre and post-tonometry with ICare Tonometer via Pentacam HR and IOL Master.	10 minutes
Secondary	Difference in corneal staining pre and post-tonometry with ICare Tonometer.	Difference in corneal staining pre and post-tonometry with ICare Tonometer as compared to the Oxford Scoring Scale.	10 minutes