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

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: Gas tamponade; Procedure: Air tamponade

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Oslo, Norway, 0424
    • Oslo University Hospital
  • Stavanger, Norway, 4016
    • Stavanger University Hospital, Department of Ophthalmology
  • Tromsø, Norway, 9038
    • University Hospital of North Norway
  • Trondheim, Norway, 7030
    • Trondheim University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular hole closure verified on OCT	Macular hole closure verified on OCT after one macular hole intervention	2 - 8 weeks postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Collaborators: Oslo University Hospital; University Hospital of North Norway; Haukeland University Hospital; Trondheim University Hospital
• Investigators: Principal Investigator: Vegard Forsaa, PhD, Helse Stavanger HF

Publications and helpful links

General Publications

• Lindtjorn B, Krohn J, Haugstad M, Stene-Johansen I, Austeng D, Basit S, Fossen K, Varhaug P, Kvaloy JT, Forsaa VA. Air versus Sulfur Hexafluoride Gas Tamponade for Small and Medium-Sized Macular Holes: A Randomized Noninferiority Trial. Ophthalmol Retina. 2022 Sep;6(9):828-834. doi: 10.1016/j.oret.2022.04.003. Epub 2022 Apr 7.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: 2018/785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No