Macular Holes
Conditions
Brief summary
This is a prospective, multicenter, randomized non-inferiority trial, where the macular hole closure rate with intraocular air tamponade is compared to the closure rate with gas tamponade.The patients are randomized to receive either air or gas (26% SF6) as intraocular tamponade, just prior to the intraocular flushing of the tamponade during the vitrectomy procedure. Postoperatively, the patients adhere to the nonsupine regimen for three days, and the tennis ball technique is used during sleep to enhance patients' positioning compliance.
Interventions
PROCEDUREGas tamponade
Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.
PROCEDUREAir tamponade
Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.
Sponsors
Haukeland University Hospital
Trondheim University Hospital
University Hospital of North Norway
Oslo University Hospital
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary macular hole ≤ 400 μm * Duration no more than 24 months * Able to sign informed content * Signed informed content
Exclusion criteria
* Earlier vitreoretinal surgery in present eye * Secondary macular holes caused by other conditions than vitreomacular traction * Myopic macular hole, i.e. excessive myopia (more than -6 dioptres) * Posttraumatic macular hole * Macular holes secondary to retinal detachment or other retinal diseases * Surgery under general anesthesia * Visual acuity below 20/40 in fellow-eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular hole closure verified on OCT | 2 - 8 weeks postoperatively | Macular hole closure verified on OCT after one macular hole intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Closure of macular holes ≤ 250 µm | 2 - 8 weeks postoperatively | Macular hole closure verified on OCT after one macular hole intervention |
| Closure of macular holes >250 µm and ≤ 400 µm | 2 - 8 weeks postoperatively | Macular hole closure verified on OCT after one macular hole intervention |
| Intraocular pressure | First postoperative day | Standard procedure for assessment of intraocular pressure |
| Visual acuity | 2 - 8 weeks postoperatively | Standard procedure for assessment of visual acuity |
Countries
Norway
Outcome results
None listed