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
Study website
Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
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(s)
Pusan National University Hospital, ref. E-2014104
Study design
Cross-sectional, comparative study
Primary study design
Observational
Secondary study design
Cross-section survey
Study setting(s)
Other
Study 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
Primary outcome measure
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 study start date
01/01/2013
Overall study end date
01/01/2023
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
160
Total final enrolment
186
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
Study 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
ROR
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
Individual participant data (IPD) Intention to share
No
IPD sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2015 | 12/02/2021 | Yes | No |