Macular HolesNCT01974310
Postoperative Positioning After Surgery for Macular Holes
A study testing Vitrectomy & Intraocular gas fill and Postoperative face-down positioning in people with Macular Holes, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Macular Holes
- What is being tested?
- Vitrectomy & Intraocular gas fill and Postoperative face-down positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Mar 2015
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic macular hole stage II-IV
- Informed consent
- Duration of symptoms ≤ 24 months
Who cannot join
- Previous vitreomacular surgery
- Myopia ≥ 8 diopters
- Ocular trauma
- Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.
Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.
Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.
- Conditions
- Macular Holes
- Being tested
- Vitrectomy & Intraocular gas fill, Postoperative face-down positioning
- Keywords
- Macular Holes, Non face down positioning, Face down positioning
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy & Intraocular gas fillProcedure or surgery
Postoperative face-down positioningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Face-down positioning | Active comparator | Patients advised face-down positioning after surgery for macular hole. Receives: Procedure: Vitrectomy & Intraocular gas fill; Procedure: Postoperative face-down positioning |
| Non-face-down positioning | Experimental | Patients advised non-face-down positioning after surgery for macular hole. Receives: Procedure: Vitrectomy & Intraocular gas fill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure rate
Macular hole closure rate assessed by optical coherence tomography
Measured: 3 months
Secondary outcomes (3)
ETDRS Visual Acuity Gain
Measured: 3 months
Degree of postoperative head incline
Position Sensor
Measured: 3 days
Degree of ocular gas fill
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionMar 2015
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
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Alberti, Glostrup University Hospital, Copenhagen
- Investigators
- Morten la Cour, Professor, Study director, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974310
- Sponsor's protocol ID
- MH-FDP-non-FDP
- Status last verified
- Feb 2016
- First submitted
- 26 Oct 2013
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.
- ClinicalTrials.gov ID
- NCT01974310
- Acronym / sponsor ID
- MH-FDP-non-FDP
- Conditions
- Macular Holes
- Keywords
- Macular Holes, Non face down positioning, Face down positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Nov 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.
Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.
Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-down positioning | Active comparator | Procedure: Vitrectomy & Intraocular gas fill, Procedure: Postoperative face-down positioningPatients advised face-down positioning after surgery for macular hole. |
| Non-face-down positioning | Experimental | Procedure: Vitrectomy & Intraocular gas fillPatients advised non-face-down positioning after surgery for macular hole. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic macular hole stage II-IV
- Informed consent
- Duration of symptoms ≤ 24 months
Key exclusion criteria (4 listed)
- Previous vitreomacular surgery
- Myopia ≥ 8 diopters
- Ocular trauma
- Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
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 |
|---|---|---|
| Vitrectomy & Intraocular gas fill | Procedure or surgery | Face-down positioning, Non-face-down positioning |
| Postoperative face-down positioning | Procedure or surgery | Face-down positioning |
Primary outcome
Macular hole closure rate
Time frame: 3 months
Macular hole closure rate assessed by optical coherence tomography
3 secondary outcomes
ETDRS Visual Acuity Gain
Time frame: 3 months
Degree of postoperative head incline
Time frame: 3 days
Degree of ocular gas fill
Time frame: 4 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 11 Feb 2016.
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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.
Morten la Cour, Professor study director
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy & Intraocular gas fill and Postoperative face-down positioning in people with Macular Holes, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 rate (time frame: 3 months). 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 11 Feb 2016.