Postoperative Positioning After Surgery for Macular Holes | NCT01974310

Studies
Postoperative Positioning After Surgery for Macular Holes

NCT01974310

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Feb 11, 2016Estimated

Enrollment

68Actual

Phase

Not Applicable

Conditions

Macular Holes

Interventions

Vitrectomy & Intraocular gas fill
Postoperative face-down positioning

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Oct 26, 2013

First Submission Date that Met QC Criteria

Oct 31, 2013

First Posted Date

Nov 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2016

Last Update Posted Date

Feb 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark Alberti, M.D., Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.

Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Face-down positioning	Active Comparator	Patients advised face-down positioning after surgery for macular hole.	Procedure: Vitrectomy & Intraocular gas fill Procedure: Postoperative face-down positioning
Non-face-down positioning	Experimental	Patients advised non-face-down positioning after surgery for macular hole.	Procedure: Vitrectomy & Intraocular gas fill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy & Intraocular gas fill	Procedure		Face-down positioning Non-face-down positioning
Postoperative face-down positioning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular hole closure rate	Macular hole closure rate assessed by optical coherence tomography	3 months

Secondary Outcomes

Measure	Description	Time Frame
ETDRS Visual Acuity Gain		3 months
Degree of postoperative head incline	Position Sensor	3 days

Other Outcomes

Measure	Description	Time Frame
Frequency of the complications		During 3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Idiopathic macular hole stage II-IV
Informed consent
Duration of symptoms ≤ 24 months

Exclusion Criteria:

Previous vitreomacular surgery
Myopia ≥ 8 diopters
Ocular trauma
Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morten la Cour, Professor	Glostrup University Hospital, Copenhagen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup Hospital, University of Copenhagen		Copenhagen		2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided