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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| Trondheim University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Oslo University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gas tamponade | Active Comparator | Gas as intraocular tamponade. |
|
| Air tamponade | Experimental | Air as intraocular tamponade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gas tamponade | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Macular hole closure verified on OCT | Macular hole closure verified on OCT after one macular hole intervention | 2 - 8 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Closure of macular holes ≤ 250 µm | Macular hole closure verified on OCT after one macular hole intervention | 2 - 8 weeks postoperatively |
| Closure of macular holes >250 µm and ≤ 400 µm | Macular hole closure verified on OCT after one macular hole intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vegard Forsaa, PhD | Helse Stavanger HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | 5021 | Norway | |||
| Oslo University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35398546 | Derived | 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. |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| OTHER |
Randomized controlled trial
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|
| Air tamponade | Procedure | 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. |
|
| 2 - 8 weeks postoperatively |
| Intraocular pressure | Standard procedure for assessment of intraocular pressure | First postoperative day |
| Visual acuity | Standard procedure for assessment of visual acuity | 2 - 8 weeks postoperatively |
| Oslo |
| 0424 |
| Norway |
| Stavanger University Hospital, Department of Ophthalmology | Stavanger | 4016 | Norway |
| University Hospital of North Norway | Tromsø | 9038 | Norway |
| Trondheim University Hospital | Trondheim | 7030 | Norway |