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

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Schiotz tonometer
UVA/riboflavin
femto-LASIK
Tomey SP-100 Pchymeter , Topolyzer Vario
Topcon CT-80, Topcon, Japan
Corvis-ST
Sponsored by
Zhiwei Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Keratoconus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shandong Provincial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

Keratoconic patients

Patients received keratoplasty

Arm Description

People without keratoconus, history of ocular surgery, and other diseases mentioned in exclusion criteria. Normal people will receive treatment or measurement including: Schiotz tonometer measurement, UVA/riboflavin corneal crosslinking, Keratoplasty, Ocular morphology measurement,and routine ophthalmic examination.

Patients with keratoconus.Keratoconic patients will receive treatment or measurement including:Schiotz tonometer measurement, UVA/riboflavin corneal crosslinking,Ocular morphology measurement,and routine ophthalmic examination.

Patients received keratoplasty. Patients received keratoplasty will receive treatment or measurement including:Schiotz tonometer measurement,Keratoplasty, Ocular morphology measurement,and routine ophthalmic examination..

Outcomes

Primary Outcome Measures

The Mulee factor obtained with Schiotz tonometer as a measure of cornea biomechanical property
Mulee factor= Value displayed with Schiotz tonometer under 7.5g load-Value displayed with Schiotz tonometer under 5.5g load

Secondary Outcome Measures

Full Information

First Posted
May 28, 2015
Last Updated
November 16, 2015
Sponsor
Zhiwei Li
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1. Study Identification

Unique Protocol Identification Number
NCT02475343
Brief Title
A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz Tonometer
Official Title
A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhiwei Li

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
People without keratoconus, history of ocular surgery, and other diseases mentioned in exclusion criteria. Normal people will receive treatment or measurement including: Schiotz tonometer measurement, UVA/riboflavin corneal crosslinking, Keratoplasty, Ocular morphology measurement,and routine ophthalmic examination.
Arm Title
Keratoconic patients
Arm Type
Experimental
Arm Description
Patients with keratoconus.Keratoconic patients will receive treatment or measurement including:Schiotz tonometer measurement, UVA/riboflavin corneal crosslinking,Ocular morphology measurement,and routine ophthalmic examination.
Arm Title
Patients received keratoplasty
Arm Type
Experimental
Arm Description
Patients received keratoplasty. Patients received keratoplasty will receive treatment or measurement including:Schiotz tonometer measurement,Keratoplasty, Ocular morphology measurement,and routine ophthalmic examination..
Intervention Type
Device
Intervention Name(s)
Schiotz tonometer
Intervention Description
The corneal biomechanical properties will be measured using a Schiotz tonometer with routine manipulation protocol.This measurement will be used in normal people, keratoconic patients, patients received keratoplasty.
Intervention Type
Device
Intervention Name(s)
UVA/riboflavin
Intervention Description
The UVA/riboflavin corneal crosslinking will be applied using a UV-X lamp (Peschke Meditrade GmbH, Switzerland) with routine manipulation protocol (3mW/cm2, 365nm, 30 minutes).This treatment will be used in keratoconic patients.
Intervention Type
Device
Intervention Name(s)
femto-LASIK
Intervention Description
The keratoplasty mainly include femto-LASIK (Laser in situ keratomileusis), which will be applied using a Wavelight FS200 and Wavelight EX500 Excimer Laser (Alcon Inc. USA.).The keratoplasty will be applied in patients who would like to receive the surgery.
Intervention Type
Device
Intervention Name(s)
Tomey SP-100 Pchymeter , Topolyzer Vario
Intervention Description
Cornea thickness will be measured with a pachymeter (Tomey SP-100 Pchymeter, Japan); cornea topography will be measured with Topolyzer Vario (Allegro, Wavelight GmBH, Germany); anterior chamber depth, white to white, and ocular axis length will be measured using a IOL master (Carl Zeiss Meditec, Germany). These measurements will be used in normal people, keratoconic patients, patients received keratoplasty.
Intervention Type
Device
Intervention Name(s)
Topcon CT-80, Topcon, Japan
Intervention Description
Vision acuity will be measured with a decimal visual chart; IOP (Intra-ocular pressure) will be measured with a tonometer (Topcon CT-80, Topcon, Japan) , fundoscopy examination will be apllied with a direct ophthalmoscopy, slit lamp examination will be applied with a slit lamp. These examinations will be used in normal people, keratoconic patients, patients received keratoplasty.
Intervention Type
Device
Intervention Name(s)
Corvis-ST
Intervention Description
Cornea biomechanical properties will be measured with a ocular response analyzer (Reichert, USA.) and/or a Corvis-ST (Oculus, Germany).These measurements will be used in normal people, keratoconic patients, patients received keratoplasty.
Primary Outcome Measure Information:
Title
The Mulee factor obtained with Schiotz tonometer as a measure of cornea biomechanical property
Description
Mulee factor= Value displayed with Schiotz tonometer under 7.5g load-Value displayed with Schiotz tonometer under 5.5g load
Time Frame
up to 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiwei Li, MD.
Phone
+86-18053106729
Email
zhiweiovs@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoying Mu, MD.
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihua Wang, MD
Email
wang_glasses@163.com

12. IPD Sharing Statement

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

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