An interventional study of Postoperative positioning advice in Macular Holes, sponsored by Helse Stavanger HF. Completed at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Treatment
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Face down positioning
Procedure: Postoperative positioning advice
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.
Macular hole mid diameter
Micrometer
Time frame: 1 day
Macular hole basal diameter
Micrometer
Time frame: 1 day
Macular hole mid area
Square micrometer
Time frame: 1 day
Central retinal thickness
Micrometer
Time frame: 1 day
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Helse Stavanger HF