MedDataX Logo

Air Tamponade in Macular Hole Surgery

NCT ID: NCT01680068

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Hole

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Macular hole Vitreoretinal surgery Macular surgery Air tamponade

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vegard Forsaa, MD

Role: STUDY_DIRECTOR

Helse Stavanger HF

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stavanger University Hospital, Department of Ophthalmology

Stavanger, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012815b

Identifier Type: -

Identifier Source: org_study_id