ISRCTN - ISRCTN09017572: Normal values for central retinal thickness asymmetry in healthy Caucasians

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janos Hargitai

ORCID ID

Contact details

Højtoftevej 2
Thisted
7700
Denmark
-
janos.hargitai@rn.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Normal values for central retinal thickness asymmetry in healthy Caucasians, measured by Spectral-Domain optical coherence tomography (OCT) posterior pole asymmetry analysis

Acronym

Study hypothesis

To determine the normal variation in central retinal thickness asymmetry in healthy Caucasians using Spectralis HRA+OCT's posterior pole asymmetry analysis.

Ethics approval

Regional Ethics Committee of North Jutland (Den Videnskabsetiske Komité for Region Nordjylland), 24/01/2014

Study design

Cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/03/2014

Overall trial end date

01/07/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy volunteer
2. Caucasian
3. Age 18-45 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/03/2014

Recruitment end date

01/07/2014

Locations

Countries of recruitment

Denmark

Trial participating centre

Højtoftevej 2
Thisted
7700
Denmark

Sponsor information

Organisation

Thy-Mors Hospital (Denmark)

Sponsor details