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Position Related Changes in Macular Hole Morphology Before and After Surgery

Position Related Changes in Macular Hole Morphology Before and After Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04676217
Enrollment
40
Registered
2020-12-19
Start date
2021-01-01
Completion date
2023-05-31
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

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.

Interventions

PROCEDUREPostoperative positioning advice

The postoperative positioning advice until 3 am the same day.

Sponsors

Helse-Bergen HF
CollaboratorOTHER
Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

RCT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Macular hole mid diameter1 dayMicrometer
Macular hole basal diameter1 dayMicrometer
Macular hole mid area1 daySquare micrometer
Central retinal thickness1 dayMicrometer

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026