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Morphologic Changes After Membrane Peeling With Air Tamponade and Balanced Salt Solution

Primary Purpose

Epiretinal Membrane, Macular Pucker

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Air tamponade
Balanced salt solution filling
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membrane focused on measuring Epiretinal membrane, Macular pucker, Membrane peeling, pars plana vitrectomy, Air, balanced salt solution, Intraoperative OCT, Hyporeflectivity, Retina

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Epiretinal membrane and the indication for surgery (visual symptoms)
  • Age 21 and older
  • written informed consent prior to surgery

Exclusion Criteria:

  • Patients who have already undergone vitrectomy
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Sites / Locations

  • Oliver Findl

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Air tamponade

Balanced salt solution filling

Arm Description

Air is injected after vitrectomy/membrane peeling

Balances salt solution is injected after vitrectomy/membrane peeling

Outcomes

Primary Outcome Measures

Proportion of eyes with presence of a hyporeflective zone on the 7th postoperative day on OCT scan
An expert in the field of reading retinal OCT scans will assess whether or not a hyporeflective zone on the 7th postoperative day is visible on the OCT scan

Secondary Outcome Measures

Change in retinal thickness 3 months after surgery assessed with OCT
Central retinal thickness assessed with OCT (µm)
Attachment of the posterior hyaloid membrane before starting surgery assessed with intraoperative OCT
An expert in the field of reading retinal OCT scans will assess intraoperative OCT scans and determine whether or not the posterior hyaloid membrane is attached to the retina before initiation of the surgery.
Best corrected visual acuity
ETDRS (Early treatment of diabetic retinopathy study) reading charts will be used to assess best corrected visual acuity

Full Information

First Posted
June 2, 2014
Last Updated
October 29, 2017
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
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1. Study Identification

Unique Protocol Identification Number
NCT02319655
Brief Title
Morphologic Changes After Membrane Peeling With Air Tamponade and Balanced Salt Solution
Official Title
Changes of the Subfoveal Hyporeflective Zone After Membrane Peeling With Air Tamponade and Balanced Salt Solution - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to remove the ERM. Different study groups showed that intraoperative use of SD-OCT is possible. Two groups already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone disappears in follow up OCT 10 days after surgery.
Detailed Description
During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to remove the ERM. Different study groups showed that intraoperative use of SD-OCT is possible. Two groups already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone disappears in follow up OCT 10 days after surgery . The aim of the study is to use a microscope integrated SD-OCT in order to measure the surgically induced hyporeflective zone in the subfoveal region during membrane peeling and to evaluate whether the hyporeflective zone, that is believed to be an expression of tissue trauma, disappears faster with air tamponade compared to eyes with balanced saline solution (BSS). Both, intraocular air tamponade and BSS are commonly used after vitrectomy with membrane peeling and pose the standard of care for this operation and no information concerning the superiority of one method is available. The non-contact microscope integrated SD-OCT, does not require any relevant additional time during the operation procedure (max. 2 minutes per operation for the OCT scans). During the OCT measurement time the light of the microscope will be reduced to a minimum to avoid additional light exposure. The OCT scans will be performed only at different time points (as mentioned below) to keep the OCT light exposure low and far below the acceptable exposure time as mentioned in the OCT safety guidelines. SD-OCT is a safe and commonly used diagnostic tool in ophthalmology and its application does not bear any additional risk for the patients included in the study. Furthermore, all devices used in this study are CE-marked (Communauté Européenne). Patients included in this study will not have a direct benefit from participation. However, it is very likely that the evaluation of the hyporeflective zone is the main indicator for the postoperative visual quality of a patient and this study will help to clarify, if air, or BSS have a protective effect for the fovea. In consequence, this study should help to use an intra-operative treatment that leads to a faster visual rehabilitation after membrane peeling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Macular Pucker
Keywords
Epiretinal membrane, Macular pucker, Membrane peeling, pars plana vitrectomy, Air, balanced salt solution, Intraoperative OCT, Hyporeflectivity, Retina

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air tamponade
Arm Type
Active Comparator
Arm Description
Air is injected after vitrectomy/membrane peeling
Arm Title
Balanced salt solution filling
Arm Type
Active Comparator
Arm Description
Balances salt solution is injected after vitrectomy/membrane peeling
Intervention Type
Procedure
Intervention Name(s)
Air tamponade
Intervention Description
Air tamponade
Intervention Type
Procedure
Intervention Name(s)
Balanced salt solution filling
Intervention Description
BSS filling
Primary Outcome Measure Information:
Title
Proportion of eyes with presence of a hyporeflective zone on the 7th postoperative day on OCT scan
Description
An expert in the field of reading retinal OCT scans will assess whether or not a hyporeflective zone on the 7th postoperative day is visible on the OCT scan
Time Frame
7 days postoperatively
Secondary Outcome Measure Information:
Title
Change in retinal thickness 3 months after surgery assessed with OCT
Description
Central retinal thickness assessed with OCT (µm)
Time Frame
3 months
Title
Attachment of the posterior hyaloid membrane before starting surgery assessed with intraoperative OCT
Description
An expert in the field of reading retinal OCT scans will assess intraoperative OCT scans and determine whether or not the posterior hyaloid membrane is attached to the retina before initiation of the surgery.
Time Frame
intraoperatively
Title
Best corrected visual acuity
Description
ETDRS (Early treatment of diabetic retinopathy study) reading charts will be used to assess best corrected visual acuity
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Epiretinal membrane and the indication for surgery (visual symptoms) Age 21 and older written informed consent prior to surgery Exclusion Criteria: Patients who have already undergone vitrectomy In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD,Prof,MBA
Organizational Affiliation
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oliver Findl
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Morphologic Changes After Membrane Peeling With Air Tamponade and Balanced Salt Solution

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