Clinical trial NCT03572725: Air Tamponade and Non-supine Positioning in Macular Hole Surgery.
Official title: Air Tamponade and Non-supine Positioning in Macular Hole Surgery. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
name: Trondheim University Hospital
name: University Hospital of North Norway
name: Oslo University Hospital
First posted: 2018-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Macular hole closure verified on OCT
timeFrame: 2 - 8 weeks postoperatively
Secondary outcomes:
measure: Closure of macular holes ≤ 250 µm
timeFrame: 2 - 8 weeks postoperatively
measure: Closure of macular holes >250 µm and ≤ 400 µm
timeFrame: 2 - 8 weeks postoperatively
measure: Intraocular pressure
timeFrame: First postoperative day
measure: Visual acuity
timeFrame: 2 - 8 weeks postoperatively
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: Trondheim University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Vegard Forsaa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindtjorn B, Krohn J, Haugstad M, Stene-Johansen I, Austeng D, Basit S, Fossen K, Varhaug P, Kvaloy JT, Forsaa VA. Air versus Sulfur Hexafluoride Gas Tamponade for Small and Medium-Sized Macular Holes: A Randomized Noninferiority Trial. Ophthalmol Retina. 2022 Sep;6(9):828-834. doi: 10.1016/j.oret.2022.04.003. Epub 2022 Apr 7.