Intraocular injection of 0.3 ml C3F8 gas for the treatment of patients with vitreomacular traction
| ISRCTN | ISRCTN10482807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10482807 |
| Secondary identifying numbers | C3F8VMT |
- Submission date
- 06/09/2017
- Registration date
- 04/10/2017
- Last edited
- 13/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Kantonsspital St.Gallen
Rorschacher Strasse 95
Haus 04
Sankt Gallen
9007
Switzerland
 ORCID ID |
0000-0003-2681-4961 |
|---|
Study information
| Study design | Interventional prospective study pre-post study design single center |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Outcome after gas injection for the treatment of vitreomacular traction |
| Study objectives | Intravitreal injection of 100% 0.3ml C3F8 Gas would release the vitreomacular traction. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2017 |
| Completion date | 01/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 26 |
| Key inclusion criteria | 1. All patients with a symptomatic vitreomacular traction 2. Aged 18 and older |
| Key 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 |
| Date of first enrolment | 01/10/2017 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
9006
Switzerland
Sponsor information
Hospital/treatment centre
Haus 04
Rorschacher Strasse 95
St.Gallen
9007
Switzerland
"ROR" |
https://ror.org/00gpmb873 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/09/2021 | 13/09/2021 | Yes | No |
Editorial Notes
13/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
08/03/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2018 to 31/12/2019.
2. The overall trial end date was changed from 31/03/2018 to 01/03/2020.
