Air Tamponade and Non-supine Positioning in Macular Hole Surgery.

Study Overview
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Brief Summary
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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.

Official Title
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Air Tamponade and Non-supine Positioning in Macular Hole Surgery. A Randomized Controlled Trial.

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: Gas tamponade
* Procedure: Air tamponade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gas tamponade<br>Gas as intraocular tamponade. | Procedure: Gas tamponade<br>* 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.<br>|
| Experimental: Air tamponade<br>Air as intraocular tamponade. | Procedure: Air tamponade<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |