Spectral-domain Optical Coherence Tomography of the Eye

• Conditions: Retina; Refractive Surgery; Cornea; Diabetes; Macular Edema; Diabetic Macular Edema

• Registration Number: NCT02614625
• Lead Sponsor: Augenabteilung Allgemeines Krankenhaus Linz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-10-12
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-22
• Last Update Submitted: 2015-11-22
• Study First Posted: 2015-11-25
• Last Update Posted: 2015-11-25
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

AKh Linz; 🇦🇹 Linz, Oberösterreich, Austria