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 |
| Protocol serial number | N/A |
| Sponsor | Pusan National University Hospital (South Korea) |
| Funder | Initiator funded |
- 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 of protocol
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
| Primary study design | Observational |
|---|---|
| Study design | Cross-sectional, comparative study |
| Secondary study design | Cross-section survey |
| Study type | Participant information sheet |
| Scientific title | The effect of corneal biomechanical properties on rebound tonometer in patients with normal tension glaucoma |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
The corneal biomechanical factors on IOP measurements with rebound tonometer, ocular response analyzer, and goldmann applanation tonometer in both NTG patients and normal subjects |
| Key secondary outcome measure(s) |
1. Agreements and reliability amongs various IOP measurements in NTG patients and normal subjects |
| Completion date | 01/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Total final enrolment | 186 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 01/01/2023 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
602-739
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
