TraumaNCT01509092
Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole
A study testing vitrectomy surgery in people with Trauma and Macular Hole, run by Peking University Third Hospital at 8 sites in China.
Trial summary
The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Macular Hole
- What is being tested?
- vitrectomy surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 8 sitesChina
- Study dates
- Jan 2012to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- closed globe injury
- identification of full-thickness macular hole by optical coherence tomography within one month after trauma
Who cannot join
- open globe injury
- coexistence of idiopathic macular hole
- severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)
- combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)
- coexistence of high myopia
- coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400μm from the center of the foveola
- coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
China - Japan Friendship Hospital
Beijing
Peking University Third Hospital
Beijing
Southwest Eye hospital of Third Military Medical University
Chongqing
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine
Shanghai
Weifang Eye Hospital
Weifang, Shandong
Wenzhou Medical College
Wenzhou, Zhejiang
Eye Hospital of Hebei Province
Xingtai, Hebei
About this study
Official title: Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial
The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.
Read the detailed description
Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.
- Conditions
- Trauma, Macular Hole
- Being tested
- vitrectomy surgery
- Keywords
- traumatic macular hole, vitrectomy, observation
- Medical subject headings
- Wounds and Injuries, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy surgeryProcedure or surgery
"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole
| Study group | Role | What they receive |
|---|---|---|
| obervation | No intervention | patients in this arm received 6-months observation alone after injury |
| Surgical intervention | Active comparator | patients in this arm received vitrectomy surgery as soon as possible after injury Receives: Procedure: vitrectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular hole closure rate
Measured: 6 month after injury
Secondary outcomes (3)
central foveal thickness
Measured: 6 month after hole closure
length of inner-segment outer-segment junction defect
Measured: 6 month after hole closure
final visual acuity
Measured: 6 month after hole closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-zhong Ma, Peking University Third Hospital
- Investigators
- Zhi-Zhong Ma, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509092
- Sponsor's protocol ID
- PekingUTH-TMH-2011
- Status last verified
- Jan 2012
- First submitted
- 28 Dec 2011
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01509092
- Acronym / sponsor ID
- PekingUTH-TMH-2011
- Conditions
- Trauma, Macular Hole
- Keywords
- traumatic macular hole, vitrectomy, observation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Jan 2012 (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 compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.
Detailed description
Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obervation | No intervention | –patients in this arm received 6-months observation alone after injury |
| Surgical intervention | Active comparator | Procedure: vitrectomy surgerypatients in this arm received vitrectomy surgery as soon as possible after injury |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- closed globe injury
- identification of full-thickness macular hole by optical coherence tomography within one month after trauma
Key exclusion criteria (7 listed)
- open globe injury
- coexistence of idiopathic macular hole
- severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)
- combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)
- coexistence of high myopia
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 surgery"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole | Procedure or surgery | Surgical intervention |
Primary outcome
macular hole closure rate
Time frame: 6 month after injury
3 secondary outcomes
central foveal thickness
Time frame: 6 month after hole closure
length of inner-segment outer-segment junction defect
Time frame: 6 month after hole closure
final visual acuity
Time frame: 6 month after hole closure
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 7 Oct 2014.
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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.
Zhi-Zhong Ma, M.D. principal investigator
Peking University Third Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy surgery in people with Trauma and Macular Hole, run by Peking University Third Hospital at 8 sites in China.
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 7 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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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: 6 month after injury). 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 7 Oct 2014.