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Spectral-domain Optical Coherence Tomography of the Eye

Sponsor
Augenabteilung Allgemeines Krankenhaus Linz (Other)
Overall Status
Unknown status
CT.gov ID
NCT02614625
Collaborator
(none)
100
Enrollment
1
Location
12
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Comparative, Observational Study on Spectral-domain Optical Coherence Tomography of the Eye
    Study Start Date :
    Dec 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Normal subjects

    Patient with healthy, normal eyes
    Eyes with corneal disease

    Subjects that have any of the following conditions Corneal dystrophy or degeneration Corneal scarring Corneal ulcer Corneal injury Keratoconus Patients who had undergone corneal surgery Patients with other corneal disease
    Eyes with retinal disease

    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
    Eyes with glaucoma

    Eyes diagnosed with glaucoma of any type and any stage

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AKh Linz Linz Oberösterreich Austria 4021

    Sponsors and Collaborators

    • Augenabteilung Allgemeines Krankenhaus Linz

    Investigators

    • Principal Investigator: Matthias Bolz, MD, AKh Linz, Augenabteilung

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Augenabteilung Allgemeines Krankenhaus Linz
    ClinicalTrials.gov Identifier:
    NCT02614625
    Other Study ID Numbers:
    • OCTComparisonstudy1.1
    First Posted:
    Nov 25, 2015
    Last Update Posted:
    Nov 25, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Nov 25, 2015