Completed

Air Tamponade in Macular Hole Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Pars plana vitrectomy and postoperative air tamponade

Procedure
Who is being recruted

Eye Diseases

+ Retinal Diseases

+ Retinal Perforations

+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorHelse Stavanger HF
Last updated: December 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01680068
Principal SponsorHelse Stavanger HF
Last updated: December 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesRetinal DiseasesRetinal Perforations

Criteria

3 inclusion criteria required to participate
Duration of symptoms <= 36 months
Idiopathic stage 2 - 4 macular hole
Informed consent
4 exclusion criteria prevent from participating
Disease affecting visual function
Myopia >= 6 diopters
Ocular trauma
Previous vitreomacular surgery

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Stavanger University Hospital, Department of Ophthalmology

Stavanger, NorwayOpen Stavanger University Hospital, Department of Ophthalmology in Google Maps
CompletedOne Study Center