Macular HolesNCT06211907
Small Macular Holes Treated With Air
A study testing Postoperative intraocular tamponade in people with Macular Holes, run by Helse Stavanger HF at 7 sites in 3 countries.
Trial summary
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes. 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?
- Postoperative intraocular tamponade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 14 Jul 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 MH ≤250 μm
- MH duration ≤12 months
- No previous vitreoretinal surgery in study eye
- Ability to sign informed consent
- Signed informed consent
- Age ˃18 years
Who cannot join
- Previous vitreoretinal surgery in study eye
- Secondary MH caused by other conditions than vitreomacular traction
- Myopic MH, i.e., excessive myopia (more than -6 dioptres)
- Traumatic MH
- MH secondary to retinal detachment or other retinal diseases
- Previously participation in this study
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Norway5 sites, 5 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, 5021
Joergen G Krohn, PhD, +4790622668, joerkroh@online.no
Pal Varhaug, MD, +4790642717, palvarhaug@helse-bergen.no
- Recruiting
Oslo University Hospital
Oslo, 0424
Marta Haugstad, MD, +4795773548, UXARGS@ous-hf.no
Ingar Stene-Johansen, MD, +4794037570, UXINTE@ous-hf.no
- Recruiting
Stavanger University Hospital
Stavanger, Rogaland, 4026
Vegard A Forsaa, PhD, +4748152212, forsaa@gmail.com
Birger Lindtjorn, PhD, +4795826869, birgerl@gmail.com
- Recruiting
University Hospital of Northern Norway
Tromsø, Troms, 9019
Kristian A Fossen, MD, +4747029181, kristian.fossen@unn.no
Nina K Angelsen, MD, Nina.Kroll.Angelsen@unn.no
- Recruiting
St. Olavs University Hospital
Trondheim, Tronderlag, 7030
Dordi K Austeng, PhD, +4747352135, dordi.austeng@ntnu.no
Terje G Fagerholt, MD, +4793223924, Terje.Giske.Fagerholt@stolav.no
Greece1 site, 1 recruiting
- Not yet recruiting
Department of Ophthalmology, University of Thessaly
Thessaly, Thessaly, 38221
Nikolaos Dervenis, Research associate, +306936615677, nikosdervenis@gmail.com
Sofia Androudi, Associate Professor, +306932654030, androudi@otenet.gr
Spain1 site, 1 recruiting
- Recruiting
Clinical Universitary Hospital of Santiago
Santiago de Compostela, La Coruna, 15706
Maria Jose Teijeiro, +34981951757, mjblantei@gmail.com
Joaquin Marticorena, PhD, +34981951757, jmarticorena@gmail.com
About this study
Official title: Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
- Conditions
- Macular Holes
- Being tested
- Postoperative intraocular 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.
Postoperative intraocular tamponadeDevice
Flushing the eye cavity with a tamponade at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Gas tamponade | Active comparator | Intravitreal gas tamponade Receives: Device: Postoperative intraocular tamponade |
| Air tamponade | Experimental | Intravitreal Air tamponade Receives: Device: Postoperative intraocular tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure after single surgery
Closure verified on OCT
Measured: 4 weeks
Secondary outcomes (2)
Change in outcome of patient well-being
Questionnaire
Measured: 4 weeks and 4 months
Change in visual acuity i ETDRS lines
Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome
Measured: 4 weeks and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start14 Jul 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-inferiority Trial
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, Oslo University Hospital, University Hospital of North Norway, University of Stavanger, Royal Liverpool University Hospital, Bangor University, Qwynedd, UK, McGill University, University Hospital Complex of Santiago de Compostela, Galicia, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211907
- Sponsor's protocol ID
- REK 580226
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT06211907
- Acronym / sponsor ID
- REK 580226
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, Oslo University Hospital, University Hospital of North Norway, University of Stavanger, Royal Liverpool University Hospital, Bangor University, Qwynedd, UK, McGill University, University Hospital Complex of Santiago de Compostela, Galicia, Spain
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Jan 2024 (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.
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority Trial
| Arm | Type | Receives |
|---|---|---|
| Gas tamponade | Active comparator | Device: Postoperative intraocular tamponadeIntravitreal gas tamponade |
| Air tamponade | Experimental | Device: Postoperative intraocular tamponadeIntravitreal Air tamponade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary MH ≤250 μm
- MH duration ≤12 months
- No previous vitreoretinal surgery in study eye
- Ability to sign informed consent
- Signed informed consent
Key exclusion criteria (6 listed)
- Previous vitreoretinal surgery in study eye
- Secondary MH caused by other conditions than vitreomacular traction
- Myopic MH, i.e., excessive myopia (more than -6 dioptres)
- Traumatic MH
- MH 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 |
|---|---|---|
| Postoperative intraocular tamponadeFlushing the eye cavity with a tamponade at the end of surgery | Device | Air tamponade, Gas tamponade |
Primary outcome
Macular hole closure after single surgery
Time frame: 4 weeks
Closure verified on OCT
2 secondary outcomes
Change in outcome of patient well-being
Time frame: 4 weeks and 4 months
Change in visual acuity i ETDRS lines
Time frame: 4 weeks and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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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.
Department of Ophthalmology, University of Thessaly
Thessaly, Greece
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative intraocular tamponade in people with Macular Holes, run by Helse Stavanger HF at 7 sites in 3 countries.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway, Greece, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular hole closure after single surgery (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.