Clinical trial NCT02614625: Spectral-domain Optical Coherence Tomography of the Eye
Official title: A Prospective, Comparative, Observational Study on Spectral-domain Optical Coherence Tomography of the Eye
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cornea
Retina
Refractive Surgery
Macular Edema
Diabetes
Diabetic Macular Edema
Lead sponsor: Augenabteilung Allgemeines Krankenhaus Linz
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 eyes of 100 patients will be included.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sensitivity as the proportion of anatomical structures that are detectable with the two instruments
timeFrame: 6 months
Secondary outcomes:
measure: Corneal sublayer thickness (µm) and retinal sublayer thickness (µm) obtained with the two study instruments
timeFrame: 6 months
measure: Corneal sublayer thickness and retinal sublayer thickness obtained with the two study instruments
timeFrame: 6 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: AKh Linz
state: Oberösterreich
Study officials:
affiliation: AKh Linz, Augenabteilung
name: Matthias Bolz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.