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

NCT ID: NCT02319655

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Epiretinal Membrane Macular Pucker

Keywords

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Epiretinal membrane Macular pucker Membrane peeling pars plana vitrectomy Air balanced salt solution Intraoperative OCT Hyporeflectivity Retina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Air tamponade

Air is injected after vitrectomy/membrane peeling

Group Type ACTIVE_COMPARATOR

Air tamponade

Intervention Type PROCEDURE

Air tamponade

Balanced salt solution filling

Balances salt solution is injected after vitrectomy/membrane peeling

Group Type ACTIVE_COMPARATOR

Balanced salt solution filling

Intervention Type PROCEDURE

BSS filling

Interventions

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Air tamponade

Air tamponade

Intervention Type PROCEDURE

Balanced salt solution filling

BSS filling

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Prim.Prof.Dr.MBA

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Oliver Findl, MD,Prof,MBA

Role: PRINCIPAL_INVESTIGATOR

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

Locations

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Oliver Findl

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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EK-14-013-0214

Identifier Type: OTHER

Identifier Source: secondary_id

MP

Identifier Type: -

Identifier Source: org_study_id