NCT03572725

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Holes

Interventions

Type	Name	Description
PROCEDURE	Gas 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.
PROCEDURE	Air 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.

Timeline

• Start date: 2018-09-26
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2018-06-28
• Last updated: 2021-09-28

Locations

5 sites across 1 country: Norway