Macular HoleNCT02011165
An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
An observational study of Macular Hole, run by Helse Stavanger HF at 2 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
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2013to Dec 2014
- Phase
- Observational
- 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
Study population: Patients undergoing pars plana vitrectomy for macular hole formation, or conditions as epiretinal menbrane or vitreomacular traction where a macular hole formation is likely.
Who may be able to join
- Pars plana vitrectomy for macular hole, vitreomacular traction or epiretinal membrane where intra ocular gas tamponade is used.
- Informed consent
Who cannot join
- Age less than 18 years
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4026
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 use the "tennis ball technique" where a tennis ball is fastened in the back of the night shirt in order to help patients compliance in avoiding the supine sleeping position. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to sleep two nights with the positioning measuring device, one night with a tennis ball in the back of the night shirt and one night without. Hereby the investigators search new knowledge concerning patients compliance and verification of the "tennis ball technique".
- Conditions
- Macular Hole
- Being tested
- Positioning measuring device
- Keywords
- Macular hole, Vitrectomy, Gas tamponade, Vitreomacular traction in danger of macular hole formation, Epiretinal membrane in danger of macular hole formation
- 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 deviceProcedure or surgery
Also called Measurement of time spent in the supine position
A tennis ball in the night shirt will prevent supine position during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Tennis ball | Night with tennis ball fastened in the back of the night shirt. A positioning measuring device mounted. Receives: Procedure: Positioning measuring device | |
| No tennis ball | Night without tennis ball fastened in the back of the night shirt. A positioning measure device mounted. Receives: Procedure: Positioning measuring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in supine sleeping position
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionDec 2014
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Vegard Forsaa, MD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011165
- Sponsor's protocol ID
- REK2013/781
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Forsaa VA, Raeder S, Hashemi LT, Krohn J. Short-term postoperative non-supine positioning versus strict face-down positioning in macular hole surgery. Acta Ophthalmol. 2013 Sep;91(6):547-51. doi: 10.1111/j.1755-3768.2012.02464.x. Epub 2012 Jul 25.
PubMed 22830524
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT02011165
- Acronym / sponsor ID
- REK2013/781
- Conditions
- Macular Hole
- Keywords
- Macular hole, Vitrectomy, Gas tamponade, Vitreomacular traction in danger of macular hole formation, Epiretinal membrane in danger of macular hole formation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Haukeland University Hospital
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Dec 2013 (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 use the "tennis ball technique" where a tennis ball is fastened in the back of the night shirt in order to help patients compliance in avoiding the supine sleeping position. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to sleep two nights with the positioning measuring device, one night with a tennis ball in the back of the night shirt and one night without. Hereby the investigators search new knowledge concerning patients compliance and verification of the "tennis ball technique".
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tennis ball | – | Procedure: Positioning measuring deviceNight with tennis ball fastened in the back of the night shirt. A positioning measuring device mounted. |
| No tennis ball | – | Procedure: Positioning measuring deviceNight without tennis ball fastened in the back of the night shirt. A positioning measure device mounted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing pars plana vitrectomy for macular hole formation, or conditions as epiretinal menbrane or vitreomacular traction where a macular hole formation is likely.
Key inclusion criteria (2 listed)
- Pars plana vitrectomy for macular hole, vitreomacular traction or epiretinal membrane where intra ocular gas tamponade is used.
- Informed consent
Key exclusion criteria (1 listed)
- Age less than 18 years
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 deviceAlso: Measurement of time spent in the supine positionA tennis ball in the night shirt will prevent supine position during sleep. | Procedure or surgery | No tennis ball, Tennis ball |
Primary outcome
Time in supine sleeping position
Time frame: Two days
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 17 Dec 2014.
- Background: PubMed 22830524Forsaa VA, Raeder S, Hashemi LT, Krohn J. Short-term postoperative non-supine positioning versus strict face-down positioning in macular hole surgery. Acta Ophthalmol. 2013 Sep;91(6):547-51. doi: 10.1111/j.1755-3768.2012.02464.x. Epub 2012 Jul 25.
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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, MD principal investigator
Helse Stavanger HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Hole, run by Helse Stavanger HF at 2 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 2 inclusion and 1 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Time in supine sleeping position (time frame: Two days). 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 NCT02011165, 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 17 Dec 2014.