Macular HoleNCT02295943
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
A study testing Positioning measuring device in people with Macular Hole, run by Helse Stavanger HF at 4 sites in Norway.
Trial summary
The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole
- What is being tested?
- Positioning measuring device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 4 sitesNorway
- Study dates
- Nov 2014to 20 Nov 2017
- 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
- Duration less than 24 months
- Informed consent
Who cannot join
- Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)
- Previous vitreomacular surgery
- Age under 18 years
- Unable to sign
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland University Hospital
Bergen, 5021
Stavanger University Hospital
Stavanger, 4011
University Hospital of North Norway
Tromsø, 9038
Trondheim University Hospital
Trondheim, 7030
About this study
The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.
- Conditions
- Macular Hole
- Being tested
- Positioning measuring device
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning measuring deviceOther
Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured
| Study group | Role | What they receive |
|---|---|---|
| Positioning measuring device | Other | The supine time during the first postoperative day is measured Receives: Other: Positioning measuring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure
Measured: 2 weeks
Secondary outcomes (1)
Time in supine sleeping position
Measured: 1 day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Why it stopped: Could not meet primary and secondary outcome measures
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 HoleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 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
- Responsible party
- Sponsor
- Investigators
- Vegard Forsaa, MD, Principal investigator, Stavanger University Hospital, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295943
- Sponsor's protocol ID
- 2014/879
- Status last verified
- Jun 2018
- First submitted
- 17 Nov 2014
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lindtjorn B, Krohn J, Austeng D, Fossen K, Varhaug P, Basit S, Helgesen OH, Eide GE, Forsaa VA. Nonsupine Positioning after Macular Hole Surgery: A Prospective Multicenter Study. Ophthalmol Retina. 2019 May;3(5):388-392. doi: 10.1016/j.oret.2018.12.006. Epub 2018 Dec 31.
PubMed 31044728
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT02295943
- Acronym / sponsor ID
- 2014/879
- Conditions
- Macular Hole
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not meet primary and secondary outcome measures
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway
- Study start
- Nov 2014 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 20 Nov 2014 (estimated)
- 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.
The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positioning measuring device | Other | Other: Positioning measuring deviceThe supine time during the first postoperative day is measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary macular hole
- Duration less than 24 months
- Informed consent
Key exclusion criteria (4 listed)
- Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)
- Previous vitreomacular surgery
- Age under 18 years
- Unable to sign
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 |
|---|---|---|
| Positioning measuring deviceVitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured | Other | Positioning measuring device |
Primary outcome
Macular hole closure
Time frame: 2 weeks
1 secondary outcome
Time in supine sleeping position
Time frame: 1 day after enrollment
Results and safety
The study was stopped early (reason given: Could not meet primary and secondary outcome measures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 31044728Lindtjorn B, Krohn J, Austeng D, Fossen K, Varhaug P, Basit S, Helgesen OH, Eide GE, Forsaa VA. Nonsupine Positioning after Macular Hole Surgery: A Prospective Multicenter Study. Ophthalmol Retina. 2019 May;3(5):388-392. doi: 10.1016/j.oret.2018.12.006. Epub 2018 Dec 31.
- Individual participant dataSharing planned: No
Related trials for Macular Hole
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Recruiting
Autologous Tenon's Capsule Graft for Refractory Macular Holes
Macular Hole Surgery
Active, not recruiting
Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
Macular Hole
Recruiting
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
Macular Holes
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, MD principal investigator
Stavanger University Hospital, Department of Ophthalmology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning measuring device in people with Macular Hole, run by Helse Stavanger HF at 4 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Could not meet primary and secondary outcome measures). Results are not available in the source record.
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 (time frame: 2 weeks). 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 NCT02295943, 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 6 Jun 2018.