Air Tamponade in Macular Hole Surgery

Not Applicable

Completed

• Conditions: Macular Hole
• Interventions: Procedure: Pars plana vitrectomy and postoperative air tamponade

• Registration Number: NCT01680068
• Lead Sponsor: Helse Stavanger HF

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pars plana vitrectomy and postoperative air tamponade	Pars plana vitrectomy and 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 Outcome Measures

Name	Time	Method
Closure rate of macular hole	1 month after enrollment

Secondary Outcome Measures

Name	Time	Method
Closure rate in macular holes larger than 400 micrometer	1 month after enrollment

Trial Locations

Locations (1)

Stavanger University Hospital, Department of Ophthalmology; 🇳🇴 Stavanger, Norway