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Completed

NCT Number: NCT03572725

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

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.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gas tamponade

Procedure

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 tamponade

Procedure

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.

Primary outcomes

  1. Macular hole closure verified on OCT

    Time frame: 2 - 8 weeks postoperatively

    Macular hole closure verified on OCT after one macular hole intervention

Secondary outcomes

  1. Closure of macular holes ≤ 250 µm

    Time frame: 2 - 8 weeks postoperatively

    Macular hole closure verified on OCT after one macular hole intervention

  2. Closure of macular holes >250 µm and ≤ 400 µm

    Time frame: 2 - 8 weeks postoperatively

    Macular hole closure verified on OCT after one macular hole intervention

  3. Intraocular pressure

    Time frame: First postoperative day

    Standard procedure for assessment of intraocular pressure

  4. Visual acuity

    Time frame: 2 - 8 weeks postoperatively

    Standard procedure for assessment of visual acuity

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Haukeland University Hospital
  • Oslo University Hospital
  • Trondheim University Hospital
  • University Hospital of North Norway

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2018
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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