Air Tamponade in Macular Holes < 400 μm

Macular Holes Clinical Trial

Official title:

Air Tamponade in Macular Holes < 400 μm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028481
• Other study ID #: 2012815b1
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: October 26, 2016
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics CommitteeNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Norway	Stavanger University Hospital, Department of Ophthalmology	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual gain after 6 months of follow up		6 months after enrollment	No
Primary	Closure rate of macular hole		1 month after enrollment	No