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

NCT02475343 | Unknown

• 1 other identifier: No.018
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• 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

  up to 1 year

Study Arms (3)

Control

EXPERIMENTAL

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.

Device: Schiotz tonometer; Device: UVA/riboflavin; Device: femto-LASIK; Device: Tomey SP-100 Pchymeter , Topolyzer Vario; Device: Topcon CT-80, Topcon, Japan; Device: Corvis-ST

Keratoconic patients

EXPERIMENTAL

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.

Device: Schiotz tonometer; Device: UVA/riboflavin; Device: Tomey SP-100 Pchymeter , Topolyzer Vario; Device: Topcon CT-80, Topcon, Japan; Device: Corvis-ST

Patients received keratoplasty

EXPERIMENTAL

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

Device: Schiotz tonometer; Device: femto-LASIK; Device: Tomey SP-100 Pchymeter , Topolyzer Vario; Device: Topcon CT-80, Topcon, Japan; Device: Corvis-ST

Interventions

Schiotz tonometer DEVICE

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.

Control; Keratoconic patients; Patients received keratoplasty

UVA/riboflavin DEVICE

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.

Control; Keratoconic patients

femto-LASIK DEVICE

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.

Control; Patients received keratoplasty

Tomey SP-100 Pchymeter , Topolyzer Vario DEVICE

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.

Control; Keratoconic patients; Patients received keratoplasty

Topcon CT-80, Topcon, Japan DEVICE

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.

Control; Keratoconic patients; Patients received keratoplasty

Corvis-ST DEVICE

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.

Control; Keratoconic patients; Patients received keratoplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhiwei Li: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Guoying Mu, MD.

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiwei Li, MD.

CONTACT

+86-18053106729; zhiweiovs@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 18, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CN (1)