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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal subjects | Patient with healthy, normal eyes | ||
| Eyes with corneal disease | Subjects that have any of the following conditions
| ||
| Eyes with retinal disease | Subjects that have any of the following conditions:
| ||
| Eyes with glaucoma | Eyes diagnosed with glaucoma of any type and any stage |
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| 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 |
| 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 |
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Inclusion Criteria:
Subjects that have any of the following conditions
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
AND
- Written informed consent prior to recruitment
Exclusion Criteria:
Any of the following will exclude a subject from the study:
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200 eyes of 100 patients will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaus Luft, MD | Contact | +43 732 7806 | 1050 | nikolaus.luft@akh.linz.at |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Bolz, MD | AKh Linz, Augenabteilung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKh Linz | Recruiting | Linz | Upper Austria | 4021 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27409470 | Derived | Luft N, Ring MH, Dirisamer M, Mursch-Edlmayr AS, Kreutzer TC, Pretzl J, Bolz M, Priglinger SG. Corneal Epithelial Remodeling Induced by Small Incision Lenticule Extraction (SMILE). Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT176-83. doi: 10.1167/iovs.15-18879. |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D008269 | Macular Edema |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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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 |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |