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Choroidal Thickness Vitrectomy

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02617147
Collaborator
(none)
76
Enrollment
1
Location
44.9
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different OCT devices.

This is a prospective, open, non-randomized, observational, MPG study This study will be performed at the Department of Ophthalmology, Medical University of Vienna.

40 Patients who undergo vitrectomy will be included into this study. The investigation will help to gain new information about the effects of vitrectomy on the choroid.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Since the development of new OCT modalities, like enhanced depth or swept-source OCT imaging, a better visualization and evaluation of retinal structures and the choroidea became possible. 23G Vitrectomy and membrane peeling seem to have an influence on posterior segment structures of the eye but data show no clear evidence evaluating those changes after surgery. Only little information is currently available on the influence or the changes resulting from vitreous surgery on the central choroidea. Hence, the aim of this study is to evaluate those influences resulting on choroidea using two different OCT devices.

    To assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different OCT devices.

    This is a prospective, open, non-randomized, observational, MPG study This study will be performed at the Department of Ophthalmology, Medical University of Vienna.

    40 Patients who undergo vitrectomy will be included into this study. The investigation will help to gain new information about the effects of vitrectomy on the choroid.

    The measuring procedures used in this study are well tolerated and used in routine clinical practice and are non-invasive.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    76 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Influence of Vitrectomy and Membrane Peeling on Choroidal Thickness
    Actual Study Start Date :
    Jun 16, 2014
    Actual Primary Completion Date :
    Mar 13, 2018
    Actual Study Completion Date :
    Mar 13, 2018

    Outcome Measures

    Primary Outcome Measures

    1. choroidal thickness using 2 different OCT devices [3 months]

    Secondary Outcome Measures

    1. Visual Acuity using Snellen charts [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with epiretinal membrane scheduled to undergo vitrectomy without endotamponade

    • Male or female, at least 18 years of age

    • Written informed consent has been obtained

    • Visual acuity ≥0.4

    Exclusion Criteria:

    • Any abnormalities preventing reliable measurements as judged by the investigator

    • Participation in a clinical trial in the 3 weeks preceding the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Medical University of Vienna, Austria Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefan Sacu, Assoz. Prof. Priv. Doz. Dr., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT02617147
    Other Study ID Numbers:
    • ophth04012014
    First Posted:
    Nov 30, 2015
    Last Update Posted:
    Oct 16, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Epiretinal Membrane

    Study Results

    No Results Posted as of Oct 16, 2019