Choroidal Thickness Vitrectomy

Completed

• Conditions: Epiretinal Membrane

• Registration Number: NCT02617147
• Lead Sponsor: Medical University of Vienna

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.

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 Timeline

• Study Start: 2014-06-16
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-11-30
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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Exclusion Criteria

• Any abnormalities preventing reliable measurements as judged by the investigator
• Participation in a clinical trial in the 3 weeks preceding the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
choroidal thickness using 2 different OCT devices	3 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity using Snellen charts	3 months

Trial Locations

Locations (1)

Department of Ophthalmology, Medical University of Vienna, Austria; 🇦🇹 Vienna, Austria