Full Thickness Macular HoleEarly Phase 1NCT01226160
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
A Early Phase 1 study testing Postoperative face-down posturing and Postoperative non-posturing group in people with Full Thickness Macular Hole, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery. 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?
- Postoperative face-down posturing and Postoperative non-posturing group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Oct 2010
- Phase
- Early Phase 1
- 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
- full thickness macular hole
- >16 years old
Who cannot join
- any history of previous intraocular surgery (including cataract surgery)
- history of ocular trauma
- history of visual loss greater than 1 year
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfileld's Eye Hospital
London, London, EC1V 2PD
About this study
This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.
- Conditions
- Full Thickness Macular Hole
- Being tested
- Postoperative face-down posturing, Postoperative non-posturing group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative face-down posturingProcedure or surgery
Postoperative face-down posturing for 10 days after surgery.
Postoperative non-posturing groupProcedure or surgery
avoid a face-up position only for 10 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Face-down posturing group | Experimental | Postoperative face-down positioning for 10 days after surgery. Receives: Procedure: Postoperative face-down posturing |
| Non-posturing group | Active comparator | avoid a face-up position for 10 days after surgery Receives: Procedure: Postoperative non-posturing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.
Measured: 6 weeks
Secondary outcomes (1)
Visual acuity assessed 6 weeks following surgery by Snellen charts.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJan 2005
- Primary completionFeb 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- 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
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226160
- Sponsor's protocol ID
- 06/Q0603/100/01
- Status last verified
- Aug 2006
- First submitted
- 21 Oct 2010
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
- ClinicalTrials.gov ID
- NCT01226160
- Acronym / sponsor ID
- 06/Q0603/100/01
- Conditions
- Full Thickness Macular Hole
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Oct 2010 (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.
This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-down posturing group | Experimental | Procedure: Postoperative face-down posturingPostoperative face-down positioning for 10 days after surgery. |
| Non-posturing group | Active comparator | Procedure: Postoperative non-posturing groupavoid a face-up position for 10 days after surgery |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- full thickness macular hole
- >16 years old
Key exclusion criteria (3 listed)
- any history of previous intraocular surgery (including cataract surgery)
- history of ocular trauma
- history of visual loss greater than 1 year
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 face-down posturingPostoperative face-down posturing for 10 days after surgery. | Procedure or surgery | Face-down posturing group |
| Postoperative non-posturing groupavoid a face-up position only for 10 days after surgery | Procedure or surgery | Non-posturing group |
Primary outcome
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.
Time frame: 6 weeks
1 secondary outcome
Visual acuity assessed 6 weeks following surgery by Snellen charts.
Time frame: 6 weeks
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 22 Oct 2010.
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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 Early Phase 1 study testing Postoperative face-down posturing and Postoperative non-posturing group in people with Full Thickness Macular Hole, run by Moorfields Eye Hospital NHS Foundation Trust 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 2 inclusion and 3 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 22 Oct 2010. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography. (time frame: 6 weeks). 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 22 Oct 2010.