Epiretinal Membrane Clinical Trial
Official title:
Changes of the Subfoveal Hyporeflective Zone After Membrane Peeling With Air Tamponade and Balanced Salt Solution - a Pilot Study
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.
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.
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