Position Related Changes in Macular Hole Morphology Before and After Surgery

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.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative positioning advice

Procedure

The postoperative positioning advice until 3 am the same day.

Primary outcomes

Macular hole mid diameter

Time frame: 1 day

Micrometer
Macular hole basal diameter

Time frame: 1 day

Micrometer
Macular hole mid area

Time frame: 1 day

Square micrometer
Central retinal thickness

Time frame: 1 day

Micrometer

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

Helse-Bergen HF

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Dec 19, 2020
Registry last updated: Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed