Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population

May 3, 2018 updated by: Tianjin Eye Hospital
Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used before and after clinical refractive surgery, we will collect the corneal morphological and biologic parameters of the population under refractive surgery screening in refractive surgery centers around the country, and construct corneal morphology database in different living areas of Chinese people. Based on this, compared with the suspected keratoconus and keratoconus population, the screening criteria and reference standards accord with the characteristics of keratoconus of Chinese ethnic will be achieved.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The safety of refractive surgery has always been the focus of attention, keratoconus screening is the most important part for the preoperative examination of refractive surgery. Favorable tools and appropriate indicators are the premise of fast and accurate screening, and the corneal morphology from various regions of China have various characteristics, the use of uniform standards developed by foreign screening will always induce a lot of problems, for example, the differences of cornea morphological features between European and American ethnic and Chinese race, as well as the corneal morphometric indicators between various regions of China, will cause varying degrees of false-positive or false-negative screening results. Based on this, in order to further improve the safety of refractive surgery effectively and to obtain the effective and accurate screening of suspected keratoconus population, this study will be conducted to collect the corneal morphological characteristics database of Chinese people from all over the country, and to develop a database of Chinese ethnographic characteristics for screening keratoconus indicators and reference valuable to guide clinical screening and surgical design.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese population of different nation from several provinces,including Jilin, Xi'an, Yunnan, Wuhan,etc.

Description

Inclusion Criteria:

  • No less than 18 years old, in good health, have no active disease in the body and eye, have permanent resident status and have lived in the local area for at least 5 years (please mark the nation).

Exclusion Criteria:

  • Eye diseases, glaucoma, ocular hypertension, glaucoma patients with normal pressure, fundus lesions, ptosis and other eyelid abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Chinese population
Chinese population of different nation from several provinces.
Device: Scheimpflug tomography system (Pentacam) measurement
The Scheimpflug tomography system (Pentacam,Oculus GmbH, Wetzlar, Germany) is a rotating Scheimpflug camera that measures 138,000 true elevation points to compute corneal topography. Patients were asked to blink twice and then look at the fixation device. Image acquisition was a 2-second scan of 50 rotational Scheimpflug images through the corneal sighting point, the point where the ray of light from the fovea to the fixation device crossed the cornea. All measurements were performed just after a blink to minimize the effect of tear film alteration on the data. Acceptable maps had at least 10.0 mm of corneal coverage with no extrapolated data in the central 9.0 mm zone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
corneal thickness
Time Frame: preoperative
preoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
corneal curvature measured by the Pentacam system
Time Frame: preoperative
preoperative
coma aberration measured by the Pentacam system
Time Frame: preoperative
preoperative
aspherical index measured by the Pentacam system
Time Frame: preoperative
preoperative
spherical aberration measured by the Pentacam system
Time Frame: preoperative
preoperative
corrected distance visual acuity
Time Frame: preoperative
preoperative
uncorrected distance visual acuity
Time Frame: preoperative
preoperative
refractive diopter
Time Frame: preoperative
preoperative
corneal volume measured by the Pentacam system
Time Frame: preoperative
preoperative
kapple angle measured by the Pentacam system
Time Frame: preoperative
preoperative
introcular pressure
Time Frame: preoperative
preoperative
corneal diameter measured by the Pentacam system
Time Frame: preoperative
preoperative
anterior chamber depth measured by the Pentacam system
Time Frame: preoperative
preoperative
anterior chamber angle measured by the Pentacam system
Time Frame: preoperative
preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Eye Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gansu Provincial Hospital
Health Science Center of Xi'an Jiaotong University
Xinjiang Medical University
Wuhan General Hospital of Guangzhou Military Command
Second People's Hospital of Yunnan Province
Jilin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yan Wang, director, Tianjin Eye Hospital
  • Principal Investigator: Xiaoyu li, Second People's Hospital of Yunnan Province
  • Principal Investigator: Yan Zhang, Jilin University
  • Principal Investigator: Jun Yang, Gansu Provincial Hospital
  • Principal Investigator: Jing Li, Health Science Center of Xi'an Jiaotong University
  • Principal Investigator: Xianglong Yi, Xinjiang Medical University
  • Principal Investigator: Zhengwei Shen, Wuhan General Hospital of Guangzhou Military Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tianjin EH-pentacam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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