Full Thickness Macular HoleNCT01020760
Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
A study testing Face down posture in people with Full Thickness Macular Hole, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Full Thickness Macular Hole
- What is being tested?
- Face down posture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2008to Oct 2010
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having surgery for idiopathic full thickness macular hole
- Able and willing to posture face-down for 10 days postoperatively
- Agree to participate in the trial and able to give informed consent
Who cannot join
- History of visual loss suggesting a duration of macular hole greater than 12 months
- Patients unable or unwilling to posture face-down for 10 days postoperatively
- History of trauma that may have been causative
- Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
- Previous vitrectomy surgery
- Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole
The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.
- Conditions
- Full Thickness Macular Hole
- Being tested
- Face down posture
- Keywords
- Macular hole, Vitrectomy, Prone posturing
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face down postureBehavioural
Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| No posture | No intervention | Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to avoid supine posturing for seven days after surgery, but will not be advised to posture in the face down or prone position. |
| Face down posture | Experimental | Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to posture in the face down or prone position for 50 minutes per hour for seven days. Receives: Behavioral: Face down posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate variance and effect size order to inform power calculations for further studies.
Measured: one year
Secondary outcomes (2)
visual acuity and complications
Measured: one year
estimate recruitment rate and establish protocol/procedure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionOct 2010
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 Full Thickness 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Yorston, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020760
- Sponsor's protocol ID
- Version 1
- Status last verified
- Apr 2012
- First submitted
- 25 Nov 2009
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Yorston D, Siddiqui MA, Awan MA, Walker S, Bunce C, Bainbridge JW. Pilot randomised controlled trial of face-down posturing following phacovitrectomy for macular hole. Eye (Lond). 2012 Feb;26(2):267-71. doi: 10.1038/eye.2011.220. Epub 2011 Sep 23.
PubMed 21941363
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole
- ClinicalTrials.gov ID
- NCT01020760
- Acronym / sponsor ID
- Version 1
- Conditions
- Full Thickness Macular Hole
- Keywords
- Macular hole, Vitrectomy, Prone posturing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Nov 2009 (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 purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No posture | No intervention | –Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to avoid supine posturing for seven days after surgery, but will not be advised to posture in the face down or prone position. |
| Face down posture | Experimental | Behavioral: Face down posturePatients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to posture in the face down or prone position for 50 minutes per hour for seven days. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having surgery for idiopathic full thickness macular hole
- Able and willing to posture face-down for 10 days postoperatively
- Agree to participate in the trial and able to give informed consent
Key exclusion criteria (6 listed)
- History of visual loss suggesting a duration of macular hole greater than 12 months
- Patients unable or unwilling to posture face-down for 10 days postoperatively
- History of trauma that may have been causative
- Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
- Previous vitrectomy surgery
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 |
|---|---|---|
| Face down posturePatients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery. | Behavioural | Face down posture |
Primary outcome
estimate variance and effect size order to inform power calculations for further studies.
Time frame: one year
2 secondary outcomes
visual acuity and complications
Time frame: one year
estimate recruitment rate and establish protocol/procedure
Time frame: one year
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 26 Apr 2012.
- Results publication: PubMed 21941363Yorston D, Siddiqui MA, Awan MA, Walker S, Bunce C, Bainbridge JW. Pilot randomised controlled trial of face-down posturing following phacovitrectomy for macular hole. Eye (Lond). 2012 Feb;26(2):267-71. doi: 10.1038/eye.2011.220. Epub 2011 Sep 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face down posture in people with Full Thickness Macular Hole, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 26 Apr 2012. 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 United Kingdom. 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?
estimate variance and effect size order to inform power calculations for further studies. (time frame: one year). 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 NCT01020760, 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 26 Apr 2012.