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01 August 2014 
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Normal values for central retinal thickness asymmetry in healthy Caucasians
ISRCTN ISRCTN09017572
DOI 10.1186/ISRCTN09017572
ClinicalTrials.gov identifier
EudraCT number
Public title Normal values for central retinal thickness asymmetry in healthy Caucasians
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 N/A
Serial number at source N/A
Study hypothesis To determine the normal variation in central retinal thickness asymmetry in healthy Caucasians using Spectralis HRA+OCT's posterior pole asymmetry analysis.
Lay 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 Hosptal, Denmark.

Who is the main contact?
Janos Hargitai
janos.hargitai@rn.dk
Ethics approval Regional Ethics Committee of North Jutland (Den Videnskabsetiske Komité for Region Nordjylland), 24/01/2014
Study design Cross-sectional study
Countries of recruitment Denmark
Disease/condition/study domain Retina
Participants - inclusion criteria 1. Healthy volunteer
2. Caucasian
3. Age 18-45 years
Participants - 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
Anticipated start date 01/03/2014
Anticipated end date 01/07/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 100
Interventions 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
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding Thy-Mors Hospital (Denmark)
Trial website
Publications
Contact name Dr  Janos  Hargitai
  Address Højtoftevej 2
  City/town Thisted
  Zip/Postcode 7700
  Country Denmark
  Email janos.hargitai@rn.dk
Sponsor Thy-Mors Hospital (Denmark)
  Address Højtoftevej 2
  City/town Thisted
  Zip/Postcode 7700
  Country Denmark
  Email janos.hargitai@rn.dk
Date applied 27/02/2014
Last edited 31/03/2014
Date ISRCTN assigned 27/03/2014
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