Position Related Changes in Macular Hole Morphology Before and After Surgery

Macular Holes Clinical Trial

Official title:

Position Related Changes in Macular Hole Morphology Before and After Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676217
• Other study ID #: 1917
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2023
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Postoperative positioning advice
The postoperative positioning advice until 3 am the same day.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital, Department of Ophthalmology	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	Helse-Bergen HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole mid diameter	Micrometer	1 day
Primary	Macular hole basal diameter	Micrometer	1 day
Primary	Macular hole mid area	Square micrometer	1 day
Primary	Central retinal thickness	Micrometer	1 day