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

Helse Stavanger HF

Status: Completed

Conditions: Macular Holes

Treatments: Procedure: Gas tamponade; Procedure: Air tamponade

Study type: Interventional

Funder types: Other

Identifiers

NCT03572725

2018/785

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Gas tamponade

Active Comparator group

Description:

Gas as intraocular tamponade.

Treatment:

Procedure: Gas tamponade

Air tamponade

Experimental group

Description:

Air as intraocular tamponade.

Treatment:

Procedure: Air tamponade