Macular HolesNCT03572725
Air Tamponade and Non-supine Positioning in Macular Hole Surgery.
A study testing Gas tamponade and Air tamponade in people with Macular Holes, run by Helse Stavanger HF at 5 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Holes
- What is being tested?
- Gas tamponade and Air tamponade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesNorway
- Study dates
- 26 Sep 2018to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary macular hole ≤ 400 μm
- Duration no more than 24 months
- Able to sign informed content
- Signed informed content
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Haukeland University Hospital
Bergen, 5021
Oslo University Hospital
Oslo, 0424
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4016
University Hospital of North Norway
Tromsø, 9038
Trondheim University Hospital
Trondheim, 7030
About this study
Official title: 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.
- Conditions
- Macular Holes
- Being tested
- Gas tamponade, Air tamponade
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gas tamponadeProcedure or surgery
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 tamponadeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Gas tamponade | Active comparator | Gas as intraocular tamponade. Receives: Procedure: Gas tamponade |
| Air tamponade | Experimental | Air as intraocular tamponade. Receives: Procedure: Air tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure verified on OCT
Macular hole closure verified on OCT after one macular hole intervention
Measured: 2 - 8 weeks postoperatively
Secondary outcomes (4)
Closure of macular holes ≤ 250 µm
Macular hole closure verified on OCT after one macular hole intervention
Measured: 2 - 8 weeks postoperatively
Closure of macular holes >250 µm and ≤ 400 µm
Macular hole closure verified on OCT after one macular hole intervention
Measured: 2 - 8 weeks postoperatively
Intraocular pressure
Standard procedure for assessment of intraocular pressure
Measured: First postoperative day
Visual acuity
Standard procedure for assessment of visual acuity
Measured: 2 - 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start26 Sep 2018
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Vegard Forsaa, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572725
- Sponsor's protocol ID
- 2018/785
- Status last verified
- Oct 2020
- First submitted
- 11 Jun 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35398546
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Tamponade and Non-supine Positioning in Macular Hole Surgery. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03572725
- Acronym / sponsor ID
- 2018/785
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway, Oslo University Hospital
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Gas tamponade | Active comparator | Procedure: Gas tamponadeGas as intraocular tamponade. |
| Air tamponade | Experimental | Procedure: Air tamponadeAir as intraocular tamponade. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary macular hole ≤ 400 μm
- Duration no more than 24 months
- Able to sign informed content
- Signed informed content
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gas tamponadeRemoval 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. | Procedure or surgery | Gas tamponade |
| Air tamponadeRemoval 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. | Procedure or surgery | Air tamponade |
Primary outcome
Macular hole closure verified on OCT
Time frame: 2 - 8 weeks postoperatively
Macular hole closure verified on OCT after one macular hole intervention
4 secondary outcomes
Closure of macular holes ≤ 250 µm
Time frame: 2 - 8 weeks postoperatively
Closure of macular holes >250 µm and ≤ 400 µm
Time frame: 2 - 8 weeks postoperatively
Intraocular pressure
Time frame: First postoperative day
Visual acuity
Time frame: 2 - 8 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 35398546Lindtjorn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard Forsaa, PhD principal investigator
Helse Stavanger HF
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gas tamponade and Air tamponade in people with Macular Holes, run by Helse Stavanger HF at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular hole closure verified on OCT (time frame: 2 - 8 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.