NCT03275142

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Comprehensive EyeCare of Central Ohio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Evaluation of Corneal Stability Post-applanation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-19
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2017-09-07
• Last updated: 2019-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study