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Position Related Changes in Macular Hole Morphology Before and After Surgery

Sponsor
Helse Stavanger HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT04676217
Collaborator
Helse-Bergen HF (Other)
80
Enrollment
2
Locations
2
Arms
37
Anticipated Duration (Months)
40
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Postoperative positioning advice
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCTRCT
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Position Related Changes in Macular Hole Morphology Before and After Surgery
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: FDP

Face down positioning

Procedure: Postoperative positioning advice
The postoperative positioning advice until 3 am the same day.
Experimental: NSP

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

Procedure: Postoperative positioning advice
The postoperative positioning advice until 3 am the same day.

Outcome Measures

Primary Outcome Measures

  1. Macular hole mid diameter [1 day]

    Micrometer

  2. Macular hole basal diameter [1 day]

    Micrometer

  3. Macular hole mid area [1 day]

    Square micrometer

  4. Central retinal thickness [1 day]

    Micrometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haukeland University Hospital Bergen Norway 5021
2 Stavanger University Hospital, Department of Ophthalmology Stavanger Norway 4016

Sponsors and Collaborators

  • Helse Stavanger HF
  • Helse-Bergen HF

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT04676217
Other Study ID Numbers:
  • 1917
First Posted:
Dec 19, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Retinal Perforations

Study Results

No Results Posted as of Sep 28, 2021