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

Sponsor

Helse Stavanger HF (Other)

Overall Status

Completed

CT.gov ID

NCT03572725

Collaborator

Haukeland University Hospital (Other), Trondheim University Hospital (Other), University Hospital of North Norway (Other), Oslo University Hospital (Other)

150

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Macular Holes	Procedure: Gas tamponade Procedure: Air tamponade	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 26, 2018

Actual Primary Completion Date :

May 28, 2021

Actual Study Completion Date :

May 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gas tamponade Gas as intraocular tamponade.	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.
Experimental: Air tamponade Air as intraocular tamponade.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Gas tamponade

Gas as intraocular tamponade.

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.

Experimental: Air tamponade

Air as intraocular tamponade.

Procedure: Air tamponade

Outcome Measures

Primary Outcome Measures

Macular hole closure verified on OCT [2 - 8 weeks postoperatively]
Macular hole closure verified on OCT after one macular hole intervention

Secondary Outcome Measures

Closure of macular holes ≤ 250 µm [2 - 8 weeks postoperatively]
Macular hole closure verified on OCT after one macular hole intervention
Closure of macular holes >250 µm and ≤ 400 µm [2 - 8 weeks postoperatively]
Macular hole closure verified on OCT after one macular hole intervention
Intraocular pressure [First postoperative day]
Standard procedure for assessment of intraocular pressure
Visual acuity [2 - 8 weeks postoperatively]
Standard procedure for assessment of visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Haukeland University Hospital	Bergen	Norway	5021
2	Oslo University Hospital	Oslo	Norway	0424
3	Stavanger University Hospital, Department of Ophthalmology	Stavanger	Norway	4016
4	University Hospital of North Norway	Tromsø	Norway	9038
5	Trondheim University Hospital	Trondheim	Norway	7030

Sponsors and Collaborators

Helse Stavanger HF
Haukeland University Hospital
Trondheim University Hospital
University Hospital of North Norway
Oslo University Hospital

Investigators

Principal Investigator: Vegard Forsaa, PhD, Helse Stavanger HF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helse Stavanger HF

ClinicalTrials.gov Identifier:

NCT03572725

Other Study ID Numbers:

2018/785

First Posted:

Jun 28, 2018

Last Update Posted:

Sep 28, 2021

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Perforations

Study Results

No Results Posted as of Sep 28, 2021