Choroidal Thickness Vitrectomy

Epiretinal Membrane Clinical Trial

Official title:

Influence of Vitrectomy and Membrane Peeling on Choroidal Thickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617147
• Other study ID #: ophth04012014
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Epiretinal Membrane

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