Air Tamponade in Macular Hole Surgery

Helse Stavanger HF

Status: Completed

Conditions: Macular Hole

Treatments: Procedure: Pars plana vitrectomy and postoperative air tamponade

Study type: Interventional

Funder types: Other

Identifiers

NCT01680068

2012815b

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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic stage 2 - 4 macular hole
• Duration of symptoms ≤ 36 months
• Informed consent

Exclusion criteria

• Previous vitreomacular surgery
• Myopia ≥ 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)

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20 participants in 1 patient group

Pars plana vitrectomy and 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: Pars plana vitrectomy and postoperative air tamponade