Air Tamponade in Macular Hole Surgery

NCT ID: NCT01680068

Last Updated: 2013-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-10-31

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.

Conditions

Macular Hole

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pars plana vitrectomy and postoperative air tamponade

Intervention Type: PROCEDURE

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

Interventions

Pars plana vitrectomy and postoperative air tamponade

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vegard Forsaa, MD

Role: STUDY_DIRECTOR

Helse Stavanger HF

Locations

Stavanger University Hospital, Department of Ophthalmology

Stavanger, , Norway

Countries

Norway

Other Identifiers

2012815b

Identifier Type: -

Identifier Source: org_study_id