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

Primary Purpose

Macular Holes

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Gas tamponade
Air tamponade
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Haukeland University Hospital
  • Oslo University Hospital
  • Stavanger University Hospital, Department of Ophthalmology
  • University Hospital of North Norway
  • Trondheim University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gas tamponade

Air tamponade

Arm Description

Gas as intraocular tamponade.

Air as intraocular tamponade.

Outcomes

Primary Outcome Measures

Macular hole closure verified on OCT
Macular hole closure verified on OCT after one macular hole intervention

Secondary Outcome Measures

Closure of macular holes ≤ 250 µm
Macular hole closure verified on OCT after one macular hole intervention
Closure of macular holes >250 µm and ≤ 400 µm
Macular hole closure verified on OCT after one macular hole intervention
Intraocular pressure
Standard procedure for assessment of intraocular pressure
Visual acuity
Standard procedure for assessment of visual acuity

Full Information

First Posted
June 11, 2018
Last Updated
September 27, 2021
Sponsor
Helse Stavanger HF
Collaborators
Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway, Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03572725
Brief Title
Air Tamponade and Non-supine Positioning in Macular Hole Surgery.
Official Title
Air Tamponade and Non-supine Positioning in Macular Hole Surgery. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway, Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gas tamponade
Arm Type
Active Comparator
Arm Description
Gas as intraocular tamponade.
Arm Title
Air tamponade
Arm Type
Experimental
Arm Description
Air as intraocular tamponade.
Intervention Type
Procedure
Intervention Name(s)
Gas tamponade
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Air tamponade
Intervention Description
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.
Primary Outcome Measure Information:
Title
Macular hole closure verified on OCT
Description
Macular hole closure verified on OCT after one macular hole intervention
Time Frame
2 - 8 weeks postoperatively
Secondary Outcome Measure Information:
Title
Closure of macular holes ≤ 250 µm
Description
Macular hole closure verified on OCT after one macular hole intervention
Time Frame
2 - 8 weeks postoperatively
Title
Closure of macular holes >250 µm and ≤ 400 µm
Description
Macular hole closure verified on OCT after one macular hole intervention
Time Frame
2 - 8 weeks postoperatively
Title
Intraocular pressure
Description
Standard procedure for assessment of intraocular pressure
Time Frame
First postoperative day
Title
Visual acuity
Description
Standard procedure for assessment of visual acuity
Time Frame
2 - 8 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Forsaa, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Stavanger University Hospital, Department of Ophthalmology
City
Stavanger
ZIP/Postal Code
4016
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Facility Name
Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35398546
Citation
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.
Results Reference
derived

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

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