Trials / Completed
CompletedNCT04676217
Position Related Changes in Macular Hole Morphology Before and After Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Helse Stavanger HF · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Postoperative positioning advice | The postoperative positioning advice until 3 am the same day. |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2023-05-31
- Completion
- 2023-05-31
- First posted
- 2020-12-19
- Last updated
- 2023-11-21
Locations
2 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT04676217. Inclusion in this directory is not an endorsement.