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

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ClinicalTrials.gov Identifier: NCT02475343
Recruitment Status : Unknown
Verified November 2015 by Zhiwei Li, Shandong Provincial Hospital.
Recruitment status was:  Recruiting
First Posted : June 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Zhiwei Li, Shandong Provincial Hospital

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.

Condition or disease Intervention/treatment Phase
Keratoconus 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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz
Study Start Date : February 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control
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
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.

Device: UVA/riboflavin
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.

Device: femto-LASIK
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.

Device: Tomey SP-100 Pchymeter , Topolyzer Vario
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.

Device: Topcon CT-80, Topcon, Japan
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.

Device: Corvis-ST
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.

Experimental: Keratoconic patients
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
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.

Device: UVA/riboflavin
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.

Device: Tomey SP-100 Pchymeter , Topolyzer Vario
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.

Device: Topcon CT-80, Topcon, Japan
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.

Device: Corvis-ST
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.

Experimental: Patients received keratoplasty
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
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.

Device: femto-LASIK
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.

Device: Tomey SP-100 Pchymeter , Topolyzer Vario
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.

Device: Topcon CT-80, Topcon, Japan
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.

Device: Corvis-ST
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 Measures :
  1. The Mulee factor obtained with Schiotz tonometer as a measure of cornea biomechanical property [ Time Frame: up to 1 year ]
    Mulee factor= Value displayed with Schiotz tonometer under 7.5g load-Value displayed with Schiotz tonometer under 5.5g load



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475343


Contacts
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Contact: Zhiwei Li, MD. +86-18053106729 zhiweiovs@hotmail.com

Locations
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China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China
Contact: Lihua Wang, MD       wang_glasses@163.com   
Sponsors and Collaborators
Zhiwei Li
Investigators
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Principal Investigator: Guoying Mu, MD. Shandong Provincial Hospital

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Responsible Party: Zhiwei Li, Dr., Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT02475343     History of Changes
Other Study ID Numbers: No.018
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents