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Position Related Changes in Macular Hole Morphology Before and After Surgery

Primary Purpose

Macular Holes

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Postoperative positioning advice
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary macular hole
  • Able to sign informed consent
  • Signed informed consent

Exclusion Criteria:

  • Previous vitreoretinal surgery in the study eye
  • Secondary macular holes caused by other conditions than vitreomacular traction
  • Myopic macular hole, i.e. excessive myopia (more than -6 dioptres)
  • Posttraumatic macular hole
  • Macular holes secondary to retinal detachment or other retinal diseases

Sites / Locations

  • Haukeland University HospitalRecruiting
  • Stavanger University Hospital, Department of OphthalmologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FDP

NSP

Arm Description

Face down positioning

No positioning named "non-supine positioning". Participants are to avoid recumbent positioning.

Outcomes

Primary Outcome Measures

Macular hole mid diameter
Micrometer
Macular hole basal diameter
Micrometer
Macular hole mid area
Square micrometer
Central retinal thickness
Micrometer

Secondary Outcome Measures

Full Information

First Posted
November 27, 2020
Last Updated
September 20, 2022
Sponsor
Helse Stavanger HF
Collaborators
Helse-Bergen HF
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1. Study Identification

Unique Protocol Identification Number
NCT04676217
Brief Title
Position Related Changes in Macular Hole Morphology Before and After Surgery
Official Title
Position Related Changes in Macular Hole Morphology Before and After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
Helse-Bergen HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Macular hole is a full thickness retinal defect in the very centre of the retina that gives the sharpest vision. The condition causes a substantial deterioration of visual acuity, and operative measures are necessary in order to close the defect and improve the visual function. A macular hole has varying degrees of retinal oedema surrounding the hole edges. The oedema is maintained by continuous of liquid into the tissue and effectively prevents spontaneous closure. For that reason it is essential for macular hole closure that the macula has minimal contact with intraocular fluid in the very early postoperative phase. This is why the treatment included a long-lasting intraocular gas tamponade and typically, one week of face-down positioning (FDP) after surgery.Our aim is to investigate the impact of diurnal, orthostatic, and gravitational variations on macular hole morphology before and after surgery. The participants will be examinated with optical coherence tomography 8-10 am, 1 pm, and 3 pm. Between 8 am and 1 pm ,the patient is encouraged to an upright position. After the 1 pm examination, the patient will be positioned flat on the side of the eye with macular hole until the 3 pm examination. The surgery will be performed before 10 am. Postoperatively a randomization to face down positioning or no positioning until 3 am. Optical coherence tomography images through gas tamponade is made at 3 am.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FDP
Arm Type
Active Comparator
Arm Description
Face down positioning
Arm Title
NSP
Arm Type
Experimental
Arm Description
No positioning named "non-supine positioning". Participants are to avoid recumbent positioning.
Intervention Type
Procedure
Intervention Name(s)
Postoperative positioning advice
Intervention Description
The postoperative positioning advice until 3 am the same day.
Primary Outcome Measure Information:
Title
Macular hole mid diameter
Description
Micrometer
Time Frame
1 day
Title
Macular hole basal diameter
Description
Micrometer
Time Frame
1 day
Title
Macular hole mid area
Description
Square micrometer
Time Frame
1 day
Title
Central retinal thickness
Description
Micrometer
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary macular hole Able to sign informed consent Signed informed consent Exclusion Criteria: Previous vitreoretinal surgery in the study eye Secondary macular holes caused by other conditions than vitreomacular traction Myopic macular hole, i.e. excessive myopia (more than -6 dioptres) Posttraumatic macular hole Macular holes secondary to retinal detachment or other retinal diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vegard Forsaa, MD, PhD
Phone
004748152212
Email
forsaa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Birger Lindtjoern, MD
Phone
004795826869
Email
birgerl@gmail.com
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joergen Krohn, PhD
Email
jorgen.krohn@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Joergen Krohn, PhD
First Name & Middle Initial & Last Name & Degree
Paal Varhaug, MD
Facility Name
Stavanger University Hospital, Department of Ophthalmology
City
Stavanger
ZIP/Postal Code
4016
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vegard Forsaa, MD
Phone
+47 48152212
Email
vegard.forsaa@sus.no
First Name & Middle Initial & Last Name & Degree
Vegard Forsaa, PhD
First Name & Middle Initial & Last Name & Degree
Birger Lindtjørn, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Position Related Changes in Macular Hole Morphology Before and After Surgery

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