To investigate the effect of corneal biomechanical properties on rebound tonometer in patients with normal tension glaucoma
| ISRCTN | ISRCTN16912051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16912051 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/08/2014
- Registration date
- 15/09/2014
- Last edited
- 12/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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
Contact information
Scientific
179 Gudeok-ro
Seo-gu
Busan
602-739
Korea, South
| Phone | +82 (0) 512407320 |
|---|---|
| jjongggal@naver.com |
Study information
| Study design | Cross-sectional, comparative study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of corneal biomechanical properties on rebound tonometer in patients with normal tension glaucoma |
| 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Total final enrolment | 186 |
| 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 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
602-739
Korea, South
Sponsor information
University/education
c/o Dr Jonghoon Shin
179 Gudeok-ro
Seo-gu
Busan-si
602-739
Korea, South
| Phone | +82 (0) 512407320 |
|---|---|
| jjongggal@naver.com | |
| Website | http://bri.pnuh.co.kr/main.action |
"ROR" |
https://ror.org/027zf7h57 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2015 | 12/02/2021 | Yes | No |
Editorial Notes
12/02/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
