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Air Tamponade in Macular Hole Surgery

Air Tamponade in Macular Hole Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01680068
Enrollment
20
Registered
2012-09-06
Start date
2012-09-30
Completion date
2013-10-31
Last updated
2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Hole

Keywords

Macular hole, Vitreoretinal surgery, Macular surgery, Air tamponade

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.

Interventions

PROCEDUREPars 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.

Sponsors

Haukeland University Hospital
CollaboratorOTHER
Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Closure rate of macular hole1 month after enrollment

Secondary

MeasureTime frame
Closure rate in macular holes larger than 400 micrometer1 month after enrollment

Other

MeasureTime frame
Visual gain after 6 months of follow up6 months after enrollment

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026