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

A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02475343
Enrollment
1000
Registered
2015-06-18
Start date
2015-02-28
Completion date
2016-06-30
Last updated
2015-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

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).

Interventions

DEVICESchiotz 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.

DEVICEUVA/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.

DEVICEfemto-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.

DEVICETomey 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.

DEVICETopcon 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.

DEVICECorvis-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.

Sponsors

Zhiwei Li
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* People without the disease mentioned in

Exclusion criteria

part.

Design outcomes

Primary

MeasureTime frameDescription
The Mulee factor obtained with Schiotz tonometer as a measure of cornea biomechanical propertyup to 1 yearMulee factor= Value displayed with Schiotz tonometer under 7.5g load-Value displayed with Schiotz tonometer under 5.5g load

Countries

China

Contacts

Primary ContactZhiwei Li, MD.
zhiweiovs@hotmail.com+86-18053106729

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026