Spectral-domain Optical Coherence Tomography of the Eye

Study Overview
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Brief Summary
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An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. However, the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative, observational study aims to evaluate the imaging quality and diagnostic performance of two commercially available SD-OCT machines for both the anterior and posterior segment of the eye.

Official Title
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A Prospective, Comparative, Observational Study on Spectral-domain Optical Coherence Tomography of the Eye

Conditions
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Cornea, Retina, Refractive Surgery, Macular Edema, Diabetes, Diabetic Macular Edema

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 and older Normal eyes or Eyes with corneal disease: Subjects that have any of the following conditions Corneal dystrophy or degeneration Corneal scarring Corneal ulcer Corneal injury Keratoconus Patients who had undergone corneal surgery Patients with other corneal disease or - Eyes with retinal disease: Subjects that have any of the following conditions: Diabetic macular edema Cystoid macular edema Age related macular degeneration Retinal vascular disorders (e.g. retinal artery occlusion) Epiretinal membrane Choroidal nevus Macular hole Patients who had undergone retinal surgery Patients with other retinal disease or Eyes with glaucoma Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant. AND - Written informed consent prior to recruitment Exclusion Criteria: Any of the following will exclude a subject from the study: Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus) Pregnancy (pregnancy test will be taken in women of reproductive age before enrolment into the trial)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal subjects<br>Patient with healthy, normal eyes | |
| Eyes with corneal disease<br>Subjects that have any of the following conditions Corneal dystrophy or degeneration Corneal scarring Corneal ulcer Corneal injury Keratoconus Patients who had undergone corneal surgery Patients with other corneal disease | |
| Eyes with retinal disease<br>Subjects that have any of the following conditions: Diabetic macular edema Cystoid macular edema Age related macular degeneration Retinal vascular disorders (e.g. retinal artery occlusion) Epiretinal membrane Choroidal nevus Macular hole Patients who had undergone retinal surgery Patients with other retinal disease | |
| Eyes with glaucoma<br>Eyes diagnosed with glaucoma of any type and any stage | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity as the proportion of anatomical structures that are detectable with the two instruments | Anatomical structures include e.g. sublayers of the cornea, sublayers of the retina, retinal vessels etc. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal sublayer thickness (µm) and retinal sublayer thickness (µm) obtained with the two study instruments | Comparability is analyzed between various biometric values obtained with the two instruments and typical indices of comparability are produced (e.g. intraclass correlation coefficient) | 6 months | 
| Corneal sublayer thickness and retinal sublayer thickness obtained with the two study instruments | Repeatability for various biometric values obtained with the two instruments is analyzed and typical indices of repeatability are produced (e.g. coefficient of variation) | 6 months |