Air Tamponade and Non-supine Positioning in Macular Hole Surgery.

Macular Holes Clinical Trial

Official title:

Air Tamponade and Non-supine Positioning in Macular Hole Surgery. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572725
• Other study ID #: 2018/785
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: May 28, 2021

Study information

• Verified date: October 2020
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multicenter, randomized non-inferiority trial, where the macular hole closure rate with intraocular air tamponade is compared to the closure rate with gas tamponade.The patients are randomized to receive either air or gas (26% SF6) as intraocular tamponade, just prior to the intraocular flushing of the tamponade during the vitrectomy procedure. Postoperatively, the patients adhere to the nonsupine regimen for three days, and the tennis ball technique is used during sleep to enhance patients' positioning compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary macular hole = 400 µm
• Duration no more than 24 months
• Able to sign informed content
• Signed informed content

Exclusion Criteria:

• Earlier vitreoretinal surgery in present 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
• Surgery under general anesthesia
• Visual acuity below 20/40 in fellow-eye

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Gas tamponade
Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.
• Air tamponade
Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Norway	Stavanger University Hospital, Department of Ophthalmology	Stavanger
Norway	University Hospital of North Norway	Tromsø
Norway	Trondheim University Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Helse Stavanger HF	Haukeland University Hospital, Oslo University Hospital, Trondheim University Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole closure verified on OCT	Macular hole closure verified on OCT after one macular hole intervention	2 - 8 weeks postoperatively
Secondary	Closure of macular holes = 250 µm	Macular hole closure verified on OCT after one macular hole intervention	2 - 8 weeks postoperatively
Secondary	Closure of macular holes >250 µm and = 400 µm	Macular hole closure verified on OCT after one macular hole intervention	2 - 8 weeks postoperatively
Secondary	Intraocular pressure	Standard procedure for assessment of intraocular pressure	First postoperative day
Secondary	Visual acuity	Standard procedure for assessment of visual acuity	2 - 8 weeks postoperatively