Air Tamponade in Macular Hole Surgery

This study has been completed.

Sponsor:

Collaborator:

Haukeland University Hospital

Information provided by (Responsible Party):

Helse Stavanger HF

ClinicalTrials.gov Identifier:

NCT01680068

First received: September 3, 2012

Last updated: December 4, 2013

Last verified: December 2013

History of Changes

Purpose

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.

Condition	Intervention
Macular Hole	Procedure: Pars plana vitrectomy and postoperative air tamponade


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Air Tamponade in Macular Hole Surgery

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:

Closure rate of macular hole [ Time Frame: 1 month after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Closure rate in macular holes larger than 400 micrometer [ Time Frame: 1 month after enrollment ] [ Designated as safety issue: No ]

Other Outcome Measures:

Visual gain after 6 months of follow up [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]


Enrollment:	20
Study Start Date:	September 2012
Study Completion Date:	October 2013
Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Procedure: 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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680068

Locations


Norway
Stavanger University Hospital, Department of Ophthalmology
Stavanger, Norway, 4016

Sponsors and Collaborators

Helse Stavanger HF

Haukeland University Hospital

Investigators


Study Director:	Vegard Forsaa, MD	Helse Stavanger HF

More Information


Responsible Party:	Helse Stavanger HF
ClinicalTrials.gov Identifier:	NCT01680068 History of Changes
Other Study ID Numbers:	2012815b
Study First Received:	September 3, 2012
Last Updated:	December 4, 2013
Health Authority:	Norway: Ethics Committee Norway: Data Protection Authority

Keywords provided by Helse Stavanger HF:


Macular hole Vitreoretinal surgery Macular surgery Air tamponade

Additional relevant MeSH terms:


Retinal Perforations Retinal Diseases Eye Diseases Temazepam Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs	Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

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