NCT03572725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 26, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

September 28, 2021

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

June 11, 2018

Last Update Submit

September 27, 2021

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (1)

  • Macular hole closure verified on OCT

    Macular hole closure verified on OCT after one macular hole intervention

    2 - 8 weeks postoperatively

Secondary Outcomes (4)

  • Closure of macular holes ≤ 250 µm

    2 - 8 weeks postoperatively

  • Closure of macular holes >250 µm and ≤ 400 µm

    2 - 8 weeks postoperatively

  • Intraocular pressure

    First postoperative day

  • Visual acuity

    2 - 8 weeks postoperatively

Study Arms (2)

Gas tamponade

ACTIVE COMPARATOR

Gas as intraocular tamponade.

Procedure: Gas tamponade

Air tamponade

EXPERIMENTAL

Air as intraocular tamponade.

Procedure: Air tamponade

Interventions

Gas tamponadePROCEDURE

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.

Gas tamponade
Air tamponadePROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4016, Norway

Location

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Trondheim University Hospital

Trondheim, 7030, Norway

Location

Related Publications (1)

  • 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.

    PMID: 35398546DERIVED

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Vegard Forsaa, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 28, 2018

Study Start

September 26, 2018

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

September 28, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(5)