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OpenTrials
Completed

NCT Number: NCT03275142

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive EyeCare of Central Ohio

Westerville, Ohio, 43082, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age

Exclusion criteria

  • Under 18 years of age

Treatment and study plan

Icare Tonometer

Device

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

Primary outcomes

  1. Demonstration of corneal stability post-applanation with the Icare tonometer.

    Time frame: 30 minutes

    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

Secondary outcomes

  1. Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.

    Time frame: 10 minutes

    Evaluation of average keratometric difference pre and post-tonometry with ICare via Pentacam HR and IOL Master.

  2. Total cylinder differences pre and post-tonometry with ICare tonometer.

    Time frame: 10 minutes

    Total cylinder differences pre and post-tonometry with ICare Tonometer via Pentacam HR and IOL Master.

  3. Difference in corneal staining pre and post-tonometry with ICare Tonometer.

    Time frame: 10 minutes

    Difference in corneal staining pre and post-tonometry with ICare Tonometer as compared to the Oxford Scoring Scale.

Sponsors and collaborators

Lead sponsor

Comprehensive EyeCare of Central Ohio

Other

Collaborators

  • Icare USA

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2017
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.