Factors Affecting Corneal Hysteresis in Taiwanese

NCT ID: NCT01235780

Last Updated: 2010-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to investigate the factors affecting corneal hysteresis (CH) in Taiwanese.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ocular response analyzer (ORA, Reichert Ophthalmic Instruments, Buffalo, NY, USA) measures the biomechanical properties of the cornea in vivo. It provides several measurements including CH, corneal resistance factor (CRF), corneal-compensated intraocular pressure (IOPcc), and Goldmann-correlated intraocular pressure (IOPg). Corneal hysteresis is described as the viscous damping due to the viscoelastic resistance of the cornea to a deformation pulse by an air jet of the tonometer. Whereas CH may reflect corneal viscosity, the CRF may relate to the elastic properties of the cornea. Both parameters are measured by the ORA using a dynamic bidirectional process.

CH can be affected by various ocular disorders and operation. In previous studies, CH was found to be significantly lower in keratoconus, Fuchs' dystrophy, and glaucoma. After laser in situ keratomileusis (LASIK) and phacoemulsification, CH permanently or temporally decreased. Among normal population, CH was also variable and associated with several factors: age, gender, intraocular pressure, central corneal thickness, and corneal curvature. High myopic patients with long axial length were found to have lower CH than in normal subjects. CH can also affected by races, and CH was largely discussed in Caucasian population. Herein we studied normal population of CH and associated factors and in Taiwan.

We are planned to conduct a retrospective study from January to July, 2009 at Department of Ophthalmology, Far Eastern Memorial Hospital, Taipei, Taiwan by chart review. We will enroll the patients with bilateral cataract, or unilateral cataract and healthy fellow eye, who not having other ocular pathology, prior ocular surgery, or previous trauma. Several ocular parameters and demographics of both un-operated eyes in these patients are measured. CRF, IOPcc, IOPg, and CH are measured by ORA. Central corneal thickness is measured using the ORA's integrated handheld ultrasonic pachymeter. The IOLMaster (Carl Zeiss, Jena, German) is used to obtain the ocular biometry including axial length, anterior chamber depth, and keratometry. Linear regression models were used to test the correlation of CH and quantitative factors. The chi-square test was used to find the significance of correlation in categorical values.

One or two eyes of the patients undergoes uneventful phacoemulsification and in-the-bag implantation of posterior chamber intraocular lens (one-piece AcrySof, Alcon lab, Texas, USA) by one surgeon (Wang JK). The sutureless corneal wound was 2.75 mm long. CRF, IOPcc, IOPg, and CH are measured by ORA preoperatively and 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, and 3 months postoperatively. Paired t test was used to compare the changes of these parameters following the operation.

We expect that some factors will correlate with CH, such as axial length, IOP, age, and central corneal thickness. Temporary reduction in CH is possibly shortly after phacoemulsification, and returning to the baseline following a period of time.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corneal Hysteresis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

corneal hysteresis, ocular response analyzer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* normal population

Exclusion Criteria

* no other ocular diseases except cataract, no prior ocular operation, no prior ocular trauma
Minimum Eligible Age

33 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Research Ethics Review Committee of Far Eastern Memorial Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jia-Kang Wang, M.D.

Role: STUDY_CHAIR

Ophthalmologic Department, Far Eastern Memorial Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

098060-3

Identifier Type: -

Identifier Source: org_study_id