NCT02028481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

January 3, 2014

Last Update Submit

October 26, 2016

Conditions

Macular Holes

Keywords

Macular holeVitreoretinal surgeryMacular surgeryAir tamponade

Outcome Measures

Primary Outcomes (1)

  • Closure rate of macular hole

    1 month after enrollment

Other Outcomes (1)

  • Visual gain after 6 months of follow up

    6 months after enrollment

Study Arms (1)

Postoperative air tamponade

EXPERIMENTAL

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

Procedure: Postoperative air tamponade

Interventions

Postoperative air tamponadePROCEDURE

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

Postoperative air tamponade

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary macular hole less than 400 μm in diameter
  • Duration of symptoms less than 36 months
  • Informed consent

You may not qualify if:

  • Previous vitreomacular surgery
  • Myopia more than 6 diopters
  • Ocular trauma
  • Disease affecting visual function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4016, Norway

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Vegard Forsaa, MD

    Helse Stavanger HF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 7, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2015

Study Completion

February 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)