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

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.

Study Overview

• Status: Completed
• Conditions: Evaluation of Corneal Stability Post-applanation
• Intervention / Treatment: Device: Icare tonometer

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Comprehensive EyeCare of Central Ohio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age

Exclusion Criteria:

• Under 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icare Applanation; Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation.	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.; Other Names: Icare; applanation; tonometry
Active Comparator: No ICare Applanation; Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation.	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.; Other Names: Icare; applanation; tonometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Comprehensive EyeCare of Central Ohio
• Collaborators: Icare USA
• Investigators: Study Director: Kenneth A Beckman, M.D., Comprehensive EyeCare of Central Ohio

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 170608-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the originating site of study will have the identity log linking the participants to the study records.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes