Plain English Summary
Background and study aims
Vitreomacular traction (VMT) is disease of the macula (the small center of the retina that is the centre of our field of vision) causing reduced vision and distortion. The managment options for VMT include pars plana vitrectomy (a procedure that involves removal the gel from the eye), enzymatic vitreolysis (a technique that uses lasers to disrupt floaters) observation. Participants may have to undergo surgery to treat VMT. Intravitreal injections of a C3F8 gas (injections into the vitreal area of the eye) might avoid surgery. The aim of this study is to investigate if pneumatic vitreolysis with intravitreal injection of 0.3ml of 100% C3F8 gas can be a cost-effective and easy alternative to release the vitreomacular traction.
Who can participate?
Adults aged 18 and older who have symptomatic vitreomacular traction.
What does the study involve?
Participants receive the procedure which includes an injection into the eye with the 0.3ml of 100% C3F8 gas. They are asked not to lie flat on the back for five days. Participants are instructed to use eyedrops three times a day for three days. Participants are followed up the next day, one week and four weeks after surgery. If the treatment was successful the participants are referred back to the private ophthalmologist (eye surgeon). If the treatment wasn’t successful further treatment is offered.
What are the possible benefits and risks of participating?
Participants may benefit from having this procedure instead of having surgery. There is risks associated with an intravitreal injections including pain, bleeding, retinal tears, infections, loss of vision, loss of eyes (from severe injections), and need for further surgery.
Where is the study run from?
Eye Clinic, Cantonal Hospital Sankt Gallen (Switzerland)
When is the study starting and how long is it expected to run for?
September 2017 to March 2018
Who is funding the study?
Investigator initiated and funded (Switzerland)
Who is the main contact?
Dr Josef Guber
Trial website
Contact information
Type
Scientific
Primary contact
Dr Josef Guber
ORCID ID
http://orcid.org/0000-0003-2681-4961
Contact details
Kantonsspital St.Gallen
Rorschacher Strasse 95
Haus 04
Sankt Gallen
9007
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C3F8VMT
Study information
Scientific title
Outcome after gas injection for the treatment of vitreomacular traction
Acronym
Study hypothesis
Intravitreal injection of 100% 0.3ml C3F8 Gas would release the vitreomacular traction.
Ethics approval
Not provided at time of registration.
Study design
Interventional prospective study pre-post study design single center
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patients with symptomatic vitreomacular traction
Intervention
Patients with symptomatic vitreomacular traction are included in this study. This procedure is performed by an experienced surgeon. The intervention takes about 10 minutes.
Injection Technique:
At the beginning a time-out is performed to confirm correct medication and correct eye. The participant is placed in near supine position. The procedure is performed in topical anesthesia only using lidocaine eyedrops. The eye and the eyelids are cleaned with Betadine and a drape is used to cover the face. An eyelid speculum holds the eye open. The location of injection is marked using an caliper: 3-3.5mm from the limbus for pseudophakes, 3.5-4.0 mm for phakic patients. The injection is performed with a short 30g needle tip usually in the superotemporal quadrant. At the end of surgery topical antibiotic is administer into the eye.
Medication:
Participants have 0.3ml of C3F8 gas injected into the eye.
Participants are asked not to lie flat on the back for five days. A topical therapy with tobramycin eyedrops 3 times for three days is prescribed.
Participants are reviewed next day, after a week and after four weeks postoperatively. Each participant receive a complete ophthalmological examination including best-corrected visual acuity and spectral domain optical coherence tomography (SD-OCT) (Spectralis HRA OCT, Heidelberg Engineering, Heidelberg, Germany) prior to surgery as well as one week and four weeks after surgery respectively.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Release of vitreomacular traction will be checked by using an optical coherence tomography at one week and four weeks postoperatively.
Secondary outcome measures
Visual acuity and central retinal thickness is measured using a Snellen chart and an optical coherence tomography at one and four weeks postoperatively.
Overall trial start date
01/09/2017
Overall trial end date
31/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients with a symptomatic vitreomacular traction
2. Aged 18 and older
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
1. Presence of Epiretinal Membrane over the macula at baseline
2. Broad VMT/VMA >1500 microns at baseline
3. History of vitrectomy/injections
4. History of laser photocoagulation to the macula in the study eye
5. High myopia
6. Aphakia
7. History of retinal detachment/breaks/Vitreous hemorrhage
8. Diabetic retinopathy, ischaemic retinopathies, retinal vein occlusio
Recruitment start date
01/10/2017
Recruitment end date
31/03/2018
Locations
Countries of recruitment
Switzerland
Trial participating centre
Eye Clinic, Cantonal Hospital Sankt Gallen
Sankt Gallen
9006
Switzerland
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/03/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list