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Air Tamponade in Macular Holes < 400 μm

H

Helse Stavanger HF

Status

Completed

Conditions

Macular Holes

Treatments

Procedure: Postoperative air tamponade

Study type

Interventional

Funder types

Other

Identifiers

NCT02028481
2012815b1

Details and patient eligibility

About

Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.

Enrollment

13 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary macular hole less than 400 μm in diameter
  • Duration of symptoms less than 36 months
  • Informed consent

Exclusion criteria

  • Previous vitreomacular surgery
  • Myopia more than 6 diopters
  • Ocular trauma
  • Disease affecting visual function

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Postoperative air tamponade
Experimental group
Description:
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
Treatment:
Procedure: Postoperative air tamponade

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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