Air Tamponade in Macular Holes < 400 μm
- Conditions
- Macular Holes
- Interventions
- Procedure: Postoperative air tamponade
- Registration Number
- NCT02028481
- 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. Only macular holes less than 400 μm will be included.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- Primary macular hole less than 400 μm in diameter
- Duration of symptoms less than 36 months
- Informed consent
- Previous vitreomacular surgery
- Myopia more than 6 diopters
- Ocular trauma
- Disease affecting visual function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Postoperative air tamponade 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
Trial Locations
- Locations (1)
Stavanger University Hospital, Department of Ophthalmology
🇳🇴Stavanger, Norway