Status unknownNCT04180111Updated Nov 27, 2019

Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

An observational study in Keratoconus, sponsored by Intuor Technologies, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 101 Years. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Intuor Technologies, Inc. · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 18
Ages: 18 Years to 101 Years
Sex: All

Study 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.

Read the detailed description

This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. 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.

Conditions studied

Keratoconus

Browse trials for

Keratoconus 313

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 18 is below the median of 130 across 97 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Intuor Technologies, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 101 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

- 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 18 participants (estimated)
Patient registry: No

Interventions

DeviceCATS Tonometer
CATS Tonometer Prism

What researchers measure

Primary outcomes

IOP measurement
comparative IOP measurement between CATS and GAT tonometer prisms
Time frame: 6 months

Study locations

1 of 1 sites recruiting

Arizona Eye Consultants
Tucson, Arizona 85710, United States
Recruiting
- Sean McCafferty, MD · Contact · sjmccafferty66@hotmail.com · 520-400-4255
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2019 (actual). Primary completion is estimated for Dec 2019, 7 months after the start.

Of 36 observational studies under Keratoconus, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 95. This study's planned 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 23, 2019
First posted: Nov 27, 2019
StartActual: May 5, 2019
Primary completionEst.: Dec 30, 2019
CompletionEst.: Dec 30, 2019
Last update: Nov 27, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04180111
Lead sponsor: Intuor Technologies, Inc.
Responsible party: Sponsor
First posted: Nov 27, 2019
Start date: May 5, 2019
Primary completion: Dec 30, 2019 (estimated)
Completion: Dec 30, 2019 (estimated)
Last update: Nov 27, 2019

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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