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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02617147
Other study ID # ophth04012014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 16, 2014
Est. completion date March 13, 2018

Study information

Verified date October 2019
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date March 13, 2018
Est. primary completion date March 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Department of Ophthalmology, Medical University of Vienna, Austria Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary choroidal thickness using 2 different OCT devices 3 months
Secondary Visual Acuity using Snellen charts 3 months
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