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

Helse Stavanger HF150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Macular Holes

Interventions

Gas tamponadePROCEDURE

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.

Air tamponadePROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Macular hole closure verified on OCT

Macular hole closure verified on OCT after one macular hole intervention

Time frame: 2 - 8 weeks postoperatively

Secondary Outcomes

Closure of macular holes ≤ 250 µm

Macular hole closure verified on OCT after one macular hole intervention

Time frame: 2 - 8 weeks postoperatively

Closure of macular holes >250 µm and ≤ 400 µm

Macular hole closure verified on OCT after one macular hole intervention

Time frame: 2 - 8 weeks postoperatively

Intraocular pressure

Standard procedure for assessment of intraocular pressure

Time frame: First postoperative day

Visual acuity

Standard procedure for assessment of visual acuity

Time frame: 2 - 8 weeks postoperatively

Data from ClinicalTrials.gov

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