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Air Tamponade in Macular Holes < 400 μm

Primary Purpose

Macular Holes

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Postoperative air tamponade

About this trial

This is an interventional treatment trial for Macular Holes focused on measuring Macular hole, Vitreoretinal surgery, Macular surgery, Air tamponade

Eligibility Criteria

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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

Sites / Locations

Stavanger University Hospital, Department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Postoperative air tamponade

Arm Description

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

Outcomes

Primary Outcome Measures

Closure rate of macular hole

Secondary Outcome Measures

Full Information

NCT ID

NCT02028481

First Posted

January 3, 2014

Last Updated

October 26, 2016

Sponsor

Helse Stavanger HF

Collaborators

Haukeland University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02028481

Brief Title

Air Tamponade in Macular Holes < 400 μm

Official Title

Air Tamponade in Macular Holes < 400 μm

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Helse Stavanger HF

Collaborators

Haukeland University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Holes

Keywords

Macular hole, Vitreoretinal surgery, Macular surgery, Air tamponade

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Postoperative air tamponade

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Postoperative air tamponade

Intervention Description

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

Primary Outcome Measure Information:

Title

Closure rate of macular hole

Time Frame

1 month after enrollment

Other Pre-specified Outcome Measures:

Title

Visual gain after 6 months of follow up

Time Frame

6 months after enrollment

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vegard Forsaa, MD

Organizational Affiliation

Helse Stavanger HF

Official's Role

Study Director

Facility Information:

Facility Name

Stavanger University Hospital, Department of Ophthalmology

City

Stavanger

ZIP/Postal Code

4016

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

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Air Tamponade in Macular Holes < 400 μm

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