KeratoconusNCT02475343
A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz Tonometer
A study testing Schiotz tonometer, UVA/riboflavin and femto-LASIK in people with Keratoconus, run by Zhiwei Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Schiotz tonometer, UVA/riboflavin and femto-LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- People without the disease mentioned in exclusion criteria part.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Lihua Wang, MD, wang_glasses@163.com
About this study
Official title: A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz
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.
Read the 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).
- Conditions
- Keratoconus
- Being tested
- Schiotz tonometer, UVA/riboflavin, femto-LASIK, Tomey SP-100 Pchymeter , Topolyzer Vario, Topcon CT-80, Topcon, Japan
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schiotz tonometerDevice
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.
UVA/riboflavinDevice
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.
femto-LASIKDevice
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.
Tomey SP-100 Pchymeter , Topolyzer VarioDevice
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.
Topcon CT-80, Topcon, JapanDevice
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.
Corvis-STDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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.. Receives: Device: Schiotz tonometer; Device: femto-LASIK; Device: Tomey SP-100 Pchymeter , Topolyzer Vario; Device: Topcon CT-80, Topcon, Japan; Device: Corvis-ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiwei Li
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhiwei Li, Shandong Provincial Hospital
- Investigators
- Guoying Mu, MD., Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475343
- Sponsor's protocol ID
- No.018
- Status last verified
- Nov 2015
- First submitted
- 28 May 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz
- ClinicalTrials.gov ID
- NCT02475343
- Acronym / sponsor ID
- No.018
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhiwei LiOther government
- Study start
- Feb 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: Schiotz tonometer, Device: UVA/riboflavin, Device: femto-LASIK, Device: Tomey SP-100 Pchymeter , Topolyzer Vario, Device: Topcon CT-80, Topcon, Japan, Device: Corvis-STPeople 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. |
| Keratoconic patients | Experimental | Device: Schiotz tonometer, Device: UVA/riboflavin, Device: Tomey SP-100 Pchymeter , Topolyzer Vario, Device: Topcon CT-80, Topcon, Japan, Device: Corvis-STPatients 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 | Experimental | Device: Schiotz tonometer, Device: femto-LASIK, Device: Tomey SP-100 Pchymeter , Topolyzer Vario, Device: Topcon CT-80, Topcon, Japan, Device: Corvis-STPatients received keratoplasty. Patients received keratoplasty will receive treatment or measurement including:Schiotz tonometer measurement,Keratoplasty, Ocular morphology measurement,and routine ophthalmic examination.. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People without the disease mentioned in exclusion criteria part.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schiotz tonometerThe 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 | Control, Keratoconic patients, Patients received keratoplasty |
| UVA/riboflavinThe 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 | Control, Keratoconic patients |
| femto-LASIKThe 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 | Control, Patients received keratoplasty |
| Tomey SP-100 Pchymeter , Topolyzer VarioCornea 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 | Control, Keratoconic patients, Patients received keratoplasty |
| Topcon CT-80, Topcon, JapanVision 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 | Control, Keratoconic patients, Patients received keratoplasty |
| Corvis-STCornea 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. | Device | Control, Keratoconic patients, Patients received keratoplasty |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoying Mu, MD. principal investigator
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schiotz tonometer, UVA/riboflavin and femto-LASIK in people with Keratoconus, run by Zhiwei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiwei Li, MD. (+86-18053106729, zhiweiovs@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mulee factor obtained with Schiotz tonometer as a measure of cornea biomechanical property (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.