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Clinical Trials/NCT04676217
NCT04676217CompletedNot Applicable

Position Related Changes in Macular Hole Morphology Before and After Surgery

Helse Stavanger HF4 sites in 1 country40 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
4
Primary Endpoint
Macular hole mid area

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Macular hole mid area

Time Frame: 1 day

Square micrometer

Central retinal thickness

Time Frame: 1 day

Micrometer

Macular hole mid diameter

Time Frame: 1 day

Micrometer

Macular hole basal diameter

Time Frame: 1 day

Micrometer

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (4)

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