Macular HolesNCT04676217
Position Related Changes in Macular Hole Morphology Before and After Surgery
A study testing Postoperative positioning advice in people with Macular Holes, run by Helse Stavanger HF at 2 sites in Norway.
Trial summary
Macular hole is a full thickness retinal defect in the very centre of the retina that gives the sharpest vision. The condition causes a substantial deterioration of visual acuity, and operative measures are necessary in order to close the defect and improve the visual function. 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 positioning advice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jan 2021to 31 May 2023
- 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
- Able to sign informed consent
- Signed informed consent
Who cannot join
- Previous vitreoretinal surgery in the study 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4016
About this study
Macular hole is a full thickness retinal defect in the very centre of the retina that gives the sharpest vision. The condition causes a substantial deterioration of visual acuity, and operative measures are necessary in order to close the defect and improve the visual function. A macular hole has varying degrees of retinal oedema surrounding the hole edges. The oedema is maintained by continuous of liquid into the tissue and effectively prevents spontaneous closure. For that reason it is essential for macular hole closure that the macula has minimal contact with intraocular fluid in the very early postoperative phase. This is why the treatment included a long-lasting intraocular gas tamponade and typically, one week of face-down positioning (FDP) after surgery.Our aim is to investigate the impact of diurnal, orthostatic, and gravitational variations on macular hole morphology before and after surgery. The participants will be examinated with optical coherence tomography 8-10 am, 1 pm, and 3 pm. Between 8 am and 1 pm ,the patient is encouraged to an upright position. After the 1 pm examination, the patient will be positioned flat on the side of the eye with macular hole until the 3 pm examination. The surgery will be performed before 10 am. Postoperatively a randomization to face down positioning or no positioning until 3 am. Optical coherence tomography images through gas tamponade is made at 3 am.
- Conditions
- Macular Holes
- Being tested
- Postoperative positioning advice
- 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 positioning adviceProcedure or surgery
The postoperative positioning advice until 3 am the same day.
| Study group | Role | What they receive |
|---|---|---|
| FDP | Active comparator | Face down positioning Receives: Procedure: Postoperative positioning advice |
| NSP | Experimental | No positioning named "non-supine positioning". Participants are to avoid recumbent positioning. Receives: Procedure: Postoperative positioning advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole mid diameter
Micrometer
Measured: 1 day
Macular hole basal diameter
Micrometer
Measured: 1 day
Macular hole mid area
Square micrometer
Measured: 1 day
Central retinal thickness
Micrometer
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jan 2021
- Primary completion31 May 2023
- Study completion31 May 2023
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
- RCT
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Helse-Bergen HF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676217
- Sponsor's protocol ID
- 1917
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position Related Changes in Macular Hole Morphology Before and After Surgery
- ClinicalTrials.gov ID
- NCT04676217
- Acronym / sponsor ID
- 1917
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Helse-Bergen HF
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 19 Dec 2020 (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.
Macular hole is a full thickness retinal defect in the very centre of the retina that gives the sharpest vision. The condition causes a substantial deterioration of visual acuity, and operative measures are necessary in order to close the defect and improve the visual function. A macular hole has varying degrees of retinal oedema surrounding the hole edges. The oedema is maintained by continuous of liquid into the tissue and effectively prevents spontaneous closure. For that reason it is essential for macular hole closure that the macula has minimal contact with intraocular fluid in the very early postoperative phase. This is why the treatment included a long-lasting intraocular gas tamponade and typically, one week of face-down positioning (FDP) after surgery.Our aim is to investigate the impact of diurnal, orthostatic, and gravitational variations on macular hole morphology before and after surgery. The participants will be examinated with optical coherence tomography 8-10 am, 1 pm, and 3 pm. Between 8 am and 1 pm ,the patient is encouraged to an upright position. After the 1 pm examination, the patient will be positioned flat on the side of the eye with macular hole until the 3 pm examination. The surgery will be performed before 10 am. Postoperatively a randomization to face down positioning or no positioning until 3 am. Optical coherence tomography images through gas tamponade is made at 3 am.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| FDP | Active comparator | Procedure: Postoperative positioning adviceFace down positioning |
| NSP | Experimental | Procedure: Postoperative positioning adviceNo positioning named "non-supine positioning". Participants are to avoid recumbent positioning. |
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
- Able to sign informed consent
- Signed informed consent
Key exclusion criteria (5 listed)
- Previous vitreoretinal surgery in the study 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 |
|---|---|---|
| Postoperative positioning adviceThe postoperative positioning advice until 3 am the same day. | Procedure or surgery | FDP, NSP |
Primary outcome
Macular hole mid diameter
Time frame: 1 day
Micrometer
Macular hole basal diameter
Time frame: 1 day
Micrometer
Macular hole mid area
Time frame: 1 day
Square micrometer
Central retinal thickness
Time frame: 1 day
Micrometer
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 21 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Macular Holes
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative positioning advice in people with Macular Holes, 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 3 inclusion and 5 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 21 Nov 2023. 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?
Macular hole mid diameter (time frame: 1 day). The study lists 4 primary outcomes in all. 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 21 Nov 2023.