A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz Tonometer

Not Applicable

• Conditions: Keratoconus

• Registration Number: NCT02475343
• Lead Sponsor: Zhiwei Li

Brief Summary

This study aims to use Schiotz tonometer to evaluate the corneal biomechanical properties. The administration of Schiotz tonometer is according to the routine protocol which is use to measure intra-ocular pressure. The results obtained from Schiotz tonometer will be compared with results obtained from ORA and/or Corvis.

Detailed Description

Schiotz tonometer, since it firstly be developed more than 100 years ago by Hjalmar Schiotz, has been regarded as a classical method to evaluate intraocular pressure (IOP). In present study, we aims to measure the corneal biomechanical properties with schiotz tonometer and elucidate the clinical significance of this novel measurement. The corneal biomechanical property was calculated with subtracting the value displayed under loaded weight 5.5g from that under loaded weight 7.5g. We named the corneal biomechanical properties obtained with schiotz tonometer as Mulee factor, and the formulation is Mulee factor=value under loaded weight 7.5g (Value 7.5G)-value under loaded weight 5.5g (Value 5.5G).

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-18
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18
• Primary Completion: 2016-05
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• People without the disease mentioned in exclusion criteria part.

Exclusion Criteria

• Patients with ocular diseases including keratitis, conjunctivitis, history of chronic eye/systemic diseases except myopia and keratoconus, history of ocular surgery except LASIK, pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Mulee factor obtained with Schiotz tonometer as a measure of cornea biomechanical property	up to 1 year	Mulee factor= Value displayed with Schiotz tonometer under 7.5g load-Value displayed with Schiotz tonometer under 5.5g load

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China