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

NCT03275142 | Completed FDA Device

• 1 other identifier: 170608-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Evaluation of Corneal Stability Post-applanation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  10 minutes

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

  10 minutes

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

  10 minutes

Study Arms (2)

Icare Applanation

EXPERIMENTAL

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

No ICare Applanation

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Icare, applanation, tonometry

Icare Applanation; No ICare Applanation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age

You may not qualify if:

• Under 18 years of age

Sponsors & Collaborators

• Comprehensive EyeCare of Central Ohio: lead
• Icare USA: collaborator

Study Sites (1)

Comprehensive EyeCare of Central Ohio

Westerville, Ohio, 43082, United States

Location

MeSH Terms

Interventions

Manometry

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kenneth A Beckman, M.D.

  Comprehensive EyeCare of Central Ohio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the Investigator will be interpreting outcomes. The technician/care provider will perform all testing and will mask the investigator to which eye tonometry was performed.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: September 7, 2017
• Study Start: June 19, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)