Three Dimension Tomography of Eye Structures by White Light Imaging Device (NCT02424266) | Clinical Trial Compass
UnknownNot Applicable
Three Dimension Tomography of Eye Structures by White Light Imaging Device
60 participantsStarted 2015-04
Plain-language summary
The purpose of this study is to investigate the ability of an imaging device, developed by AdOM Advanced Optical Technologies Ltd. ("AdOM"). The device allows a three-dimensional imaging of the ocular tissues, specifically the tear film layers and the retinal layers. The device is based on the use of white light.
In this initial study, the device will be used to assess the tear film which coats the corneal surface in healthy subjects as well as in moderate-to-severe Keratoconjunctivitis Sicca (KCS) or Dry Eye Syndrome (DES). The ability of the device to assess the retinal layers will be evaluated in the second phase of the study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The presence of at least one ocular symptom of dryness scored at \> 2 (where 0 = none and 4 = very severe /interferes with normal activities)
✓. Positive Schirmer test (ST without anesthesia) \< 7 mm/5 min in either eye
✓. Positive fluorescein stainig (FS), defined as a corneal punctate fluorescein staining score of \> 1 in either eye, where 0 = none and 3 = severe.
Exclusion criteria
✕. Stevens-Johnson Syndrome
✕. Post-burn ocular injury
✕. Chronic ocular disease other than KCS requiring topical treatment
✕. Ocular herpes simplex virus infection
✕. Use of contact lenses
✕. Persistent Intraocular Inflammation or Infection