Condition category
Eye Diseases
Date applied
08/08/2014
Date assigned
15/09/2014
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Glaucoma is an eye condition caused by a build-up of pressure within the eye (the intraocular pressure or IOP). It develops when the fluid in the eye is not able to drain properly. If untreated, it can seriously affect sight and eventually lead to blindness. Here, we want to investigate the effects of the structure and functioning (biomechanical properties) of the cornea (the transparent lens in front of the eye) on IOP measurements taken with two different types of rebound tonometry (the method used to measure IOP),the ICare ocular response analyzer (ORA) and goldmann applanation tonometry (GAT) in patients with glaucoma.

Who can participate?
Adults aged at least 18, with or without glaucoma from the Glaucoma Clinic in the Pusan National University Hospital (South Korea)

What does the study involve?
All participants undergo a ophthalmologic (eye) examination, and then their IOP is measured using the ocular response analyser and goldmann applanation tonometer.

What are the possible benefits and risks of participating?
There will be no direct benefits and risks to those taking part.

Where is the study run from?
Glaucoma clinics in Pusan National University Hospital (South Korea)

Who is funding the study?
Initiator funded

Who is the main contact?
Dr Jonghoon Shin, jjongggal@naver.com
Dr Ji-Woong Lee, glaucoma@pusan.ac.kr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonghoon Shin

ORCID ID

Contact details

179 Gudeok-ro
Seo-gu
Busan
602-739
Korea
South
+82 (0) 512407320
jjongggal@naver.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of corneal biomechanical properties on rebound tonometer in patients with normal tension glaucoma

Acronym

Study hypothesis

The corneal hysteresis is significantly lower and corneal-compensated IOP (IOPcc) is significant higher in normal tension glaucoma (NTG) patient than normal subjects.In addition, applanation tonometer and IOPcc may be greater in NTG than in either normal or high tension glaucoma (HTG) eyes. The null hypothesis is that the relationships between rebound tonometer and IOPcc may be different in NTG eyes with normal eyes.

Ethics approval

Pusan National University Hospital, ref. E-2014104

Study design

Cross-sectional, comparative study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Glaucoma

Intervention

The participants have underwent the following ophthalmic examinations : slit lamp examination, fundoscopy, automated visual field examination, and IOP measurement with goldmann applanation tonometer, rebound tonometer, and ocular response analyzer

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The corneal biomechanical factors on IOP measurements with rebound tonometer, ocular response analyzer, and goldmann applanation tonometer in both NTG patients and normal subjects

Secondary outcome measures

1. Agreements and reliability amongs various IOP measurements in NTG patients and normal subjects
2. Reliability and repeatability between rebound tonometer and other tonometers

Overall trial start date

01/01/2013

Overall trial end date

01/01/2023

Reason abandoned

Eligibility

Participant inclusion criteria

1. >18 years of age
2. Clear corneas and clear ocular media
3. Best corrective visual acuity > 20/40
4. Refractive error within ¡À 5.0 diopter of 0, and astigmatism ¡À 3.0D of 0

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. General condition : diabetes
2. Ocular condition : uveitis, secondary glaucoma, corneal abnormalities, nonglaucomatous optic neuropathies, previous trauma, ocular surgery or laser treatment, or any other eye diseases other than glaucoma

Recruitment start date

01/01/2013

Recruitment end date

01/01/2023

Locations

Countries of recruitment

Korea, South

Trial participating centre

179 Gudeok-ro
Busan
602-739
Korea, South

Sponsor information

Organisation

Pusan National University Hospital (South Korea)

Sponsor details

c/o Dr Jonghoon Shin
179 Gudeok-ro
Seo-gu
Busan-si
602-739
Korea
South
+82 (0) 512407320
jjongggal@naver.com

Sponsor type

University/education

Website

http://bri.pnuh.co.kr/main.action

Funders

Funder type

Other

Funder name

Initiator funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes