Overview

This trial has been completed.

Condition macular holes
Treatment postoperative air tamponade
Sponsor Helse Stavanger HF
Collaborator Haukeland University Hospital
Start date December 2013
End date September 2015
Trial size 13 participants
Trial identifier NCT02028481, 2012815b1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
postoperative air tamponade
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.

Primary Outcomes

Measure
Closure rate of macular hole
time frame: 1 month after enrollment

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Air Tamponade in Macular Holes < 400 μm
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Helse Stavanger HF.