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
Verified date | October 2017 |
Source | Vienna Institute for Research in Ocular Surgery |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Austria | Oliver Findl | Vienna |
Lead Sponsor | Collaborator |
---|---|
Prim. Prof. Dr. Oliver Findl, MBA |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 7 days postoperatively | |
Secondary | Change in retinal thickness 3 months after surgery assessed with OCT | Central retinal thickness assessed with OCT (µm) | 3 months | |
Secondary | 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. | intraoperatively | |
Secondary | Best corrected visual acuity | ETDRS (Early treatment of diabetic retinopathy study) reading charts will be used to assess best corrected visual acuity | 3 months postoperatively |
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