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

Not Applicable

Completed

• Conditions: Macular Holes
• Interventions: Procedure: Gas tamponade; Procedure: Air tamponade

• Registration Number: NCT03572725
• Lead Sponsor: Helse Stavanger HF

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-28
• Study Start: 2018-09-26
• Status Verified: 2020-10
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gas tamponade	Gas tamponade	Gas as intraocular tamponade.
Air tamponade	Air tamponade	Air as intraocular tamponade.

Primary Outcome Measures

Name	Time	Method
Macular hole closure verified on OCT	2 - 8 weeks postoperatively	Macular hole closure verified on OCT after one macular hole intervention

Secondary Outcome Measures

Name	Time	Method
Closure of macular holes >250 µm and ≤ 400 µm	2 - 8 weeks postoperatively	Macular hole closure verified on OCT after one macular hole intervention
Closure of macular holes ≤ 250 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

Trial Locations

Locations (5)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway

Stavanger University Hospital, Department of Ophthalmology; 🇳🇴 Stavanger, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Trondheim University Hospital; 🇳🇴 Trondheim, Norway