NCT04180111

Brief Summary

The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

November 23, 2019

Last Update Submit

November 26, 2019

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • IOP measurement

    comparative IOP measurement between CATS and GAT tonometer prisms

    6 months

Interventions

CATS TonometerDEVICE

CATS Tonometer Prism

Eligibility Criteria

Age18 Years - 101 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty three (23) Subjects 18 years and older and will be enrolled from one clinical. Subjects will be chosen from patients who are being examined for a corneal cross-linking procedure.

You may qualify if:

  • Male and female patients, at least 18 years of age
  • Subject has a clear understanding and agrees to all the conditions of the informed consent form

You may not qualify if:

  • Subject has undergone ocular surgery within the last 3 months
  • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
  • Pregnant or nursing women
  • Those who have had corneal surgery including corneal laser surgery
  • Microphthalmos
  • Buphthalmos
  • Severe Dry eyes
  • Lid squeezers - blepharospasm
  • Nystagmus
  • corneal or conjunctival infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Eye Consultants

Tucson, Arizona, 85710, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2019

First Posted

November 27, 2019

Study Start

May 5, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)