Normal values for central retinal thickness asymmetry in healthy Caucasians
| ISRCTN | ISRCTN09017572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09017572 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/02/2014
- Registration date
- 27/03/2014
- Last edited
- 16/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma is a term that describes a group of eye conditions that affect vision. Several previous studies in glaucoma patients have shown the importance of structural changes in the retina, a complex layer of tissue at the back of your eye. Optical coherence tomography (OCT) is a technique which uses a light beam to scan the different layers of the retina and can detect very subtle changes. A new OCT software assesses any possible asymmetry between the two eyes and the upper and lower hemisphere in both eyes. Recent studies have found that retinal asymmetry may be the first sign in the development of glaucoma. However, at present we have no information regarding the 'normal' asymmetry values in healthy individuals, therefore it is hard to distinguish 'normal' asymmetry from asymmetries which may be early signs of glaucoma. Our aim is to study the retinal asymmetry that normally exists in healthy individuals.
Who can participate?
Healthy volunteers between the ages of 18 and 45 who have no eye disease and have normal visual acuity with no or minor correction (glasses or contact lenses).
What does the study involve?
Every volunteer will undergo a general eye examination (visual acuity and slit lamp examination) and an OCT scan.
What are the possible benefits and risks of participating?
Volunteers participating in our study may have the benefit of a detailed eye examination. The study has no extra risk in comparison to a general eye examination.
Where is the study run from?
Our study will run at the Department of Ophthalmology, Thy-Mors Hospital in Thisted, Denmark.
When is the study starting and how long is it expected to run for?
The study will run from March 2014 to July 2014.
Who is funding the study?
Department of Ophthalmology, Thy-Mors Hospital, Denmark.
Who is the main contact?
Janos Hargitai
janos.hargitai@rn.dk
Contact information
Scientific
Højtoftevej 2
Thisted
7700
Denmark
| janos.hargitai@rn.dk |
Study information
| Study design | Cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Normal values for central retinal thickness asymmetry in healthy Caucasians, measured by Spectral-Domain optical coherence tomography (OCT) posterior pole asymmetry analysis |
| Study objectives | To determine the normal variation in central retinal thickness asymmetry in healthy Caucasians using Spectralis HRA+OCT's posterior pole asymmetry analysis. |
| Ethics approval(s) | Regional Ethics Committee of North Jutland (Den Videnskabsetiske Komité for Region Nordjylland), 24/01/2014 |
| Health condition(s) or problem(s) studied | Retina |
| Intervention | 1. Visual acuity measured using the Snellen Chart 2. Retinal thickness and RNFL measured by Spectralis HRA+OCT's volume and circle scan mode, respectively |
| Intervention type | Other |
| Primary outcome measure | 1. Right eye - left eye retinal thickness asymmetry of the paired 64 cells in the posterior pole retina thickness map 2. Superior-inferior retinal thickness asymmetry of the paired 32 cells Outcome measures will be assessed at baseline. |
| Secondary outcome measures | 1. Variance in asymmetry across the macula 2. Association between the temporal RNFL thickness and the mean central retinal thickness 3. Effect of age and sex on interocular asymmetry Outcome measures will be assessed at baseline. |
| Overall study start date | 01/03/2014 |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Healthy volunteer 2. Caucasian 3. Age 18-45 years |
| Key exclusion criteria | 1. Visual acuity < 1.0 2. Spherical equivalent > 1.5 D 3. Morphological changes in macula 4. Retinal nerve fiber layer (RNFL) thickness out of normal limits |
| Date of first enrolment | 01/03/2014 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- Denmark
Study participating centre
7700
Denmark
Sponsor information
Hospital/treatment centre
Højtoftevej 2
Thisted
7700
Denmark
| janos.hargitai@rn.dk |
Funders
Funder type
Hospital/treatment centre
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 | 01/06/2015 | Yes | No |
