Spectral-domain Optical Coherence Tomography of the Eye

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02614625
• Other study ID #: OCTComparisonstudy1.1
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2015
• Last updated: November 22, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Augenabteilung Allgemeines Krankenhaus Linz
• Contact: Nikolaus Luft, MD
• Phone: +43 732 7806
• Email: nikolaus.luft[@]akh.linz.at
• Is FDA regulated: No
• Health authority: Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cornea
• Diabetes
• Diabetic Macular Edema
• Edema
• Macular Edema
• Refractive Surgery
• Retina

Locations

Country	Name	City	State
Austria	AKh Linz	Linz	Oberösterreich

Sponsors (1)

Lead Sponsor	Collaborator
Augenabteilung Allgemeines Krankenhaus Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No