Air Tamponade in Macular Holes < 400 μm

N/ACompletedNCT02028481

Helse Stavanger HF13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Holes

Interventions

Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Stavanger University Hospital, Department of Ophthalmology

Stavanger, Norway

Outcomes

Primary Outcomes

Closure rate of macular hole

Time frame: 1 month after enrollment

Data from ClinicalTrials.gov

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