Cornea, Diabetes, Diabetic Macular Edema, Macular Edema, Refractive Surgery, Retina
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Augenabteilung Allgemeines Krankenhaus Linz
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 21 and older * Normal eyes or * Eyes with corneal disease: Subjects that have any of the following conditions 1. Corneal dystrophy or degeneration 2. Corneal scarring 3. Corneal ulcer 4. Corneal injury 5. Keratoconus 6. Patients who had undergone corneal surgery 7. Patients with other corneal disease or - Eyes with retinal disease: Subjects that have any of the following conditions: 1. Diabetic macular edema 2. Cystoid macular edema 3. Age related macular degeneration 4. Retinal vascular disorders (e.g. retinal artery occlusion) 5. Epiretinal membrane 6. Choroidal nevus 7. Macular hole 8. Patients who had undergone retinal surgery 9. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity as the proportion of anatomical structures that are detectable with the two instruments | 6 months | Anatomical structures include e.g. sublayers of the cornea, sublayers of the retina, retinal vessels etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal sublayer thickness (µm) and retinal sublayer thickness (µm) obtained with the two study instruments | 6 months | Comparability is analyzed between various biometric values obtained with the two instruments and typical indices of comparability are produced (e.g. intraclass correlation coefficient) |
| Corneal sublayer thickness and retinal sublayer thickness obtained with the two study instruments | 6 months | Repeatability for various biometric values obtained with the two instruments is analyzed and typical indices of repeatability are produced (e.g. coefficient of variation) |
Countries
Austria
Contacts
Primary ContactNikolaus Luft, MD
Outcome results
None listed