Idiopathic Macula HoleNCT02584062
Clinical Observation of Technologic Application of No-touch Fluid-air Exchange in Surgery of Idiopathic Macula Hole
A study testing no-touch fluid-air exchange and vitrectomy metrectomy and internal membrane peeling and gas tamponed in people with Idiopathic Macula Hole, run by Tianjin Medical University Eye Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe the technologic application of no-touch fluid-air exchange in Surgery of Idiopathic Macula Hole. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Idiopathic Macula Hole
- What is being tested?
- no-touch fluid-air exchange and vitrectomy metrectomy and internal membrane peeling and gas tamponed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2016to 18 Jun 2018
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were diagnosed as having an idiopathic macular hole(IMH) by Optical Coherence Tomography(OCT).
Who cannot join
- Myopia of >6 diopters
- Ocular trauma and other systematic or ocular issues associated with IMHs，such as the other macula disease, for example the degeneration of macula.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: The Eye Hospital of Tianjin Medical University
The purpose of this study is to observe the technologic application of no-touch fluid-air exchange in Surgery of Idiopathic Macula Hole.
- Conditions
- Idiopathic Macula Hole
- Being tested
- no-touch fluid-air exchange, vitrectomy metrectomy and internal membrane peeling and gas tamponed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no-touch fluid-air exchangeProcedure or surgery
Also called vitrectomy metrectomy and internal membrane peeling and gas tamponed
vitrectomy metrectomy and internal membrane peeling and gas tamponedProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| no-touch fluid-air exchange group | Experimental | All patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will not touch the macular area,especially the area of the macular hole and investigator will not have the fluid-air exchange of the macular area. Receives: Procedure: no-touch fluid-air exchange; Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponed |
| the tradional group | Experimental | All patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will touch the macular area and investigator will have the fluid-air exchange. Receives: Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponed |
What is being measured
The primary outcome is the main question the study is designed to answer.
the closure rate of Macular hole
the closure rate of macular hole through OCT
Measured: one month
the closure rate of Macular hole
the closure rate of Macular hole
Measured: three month
the closure rate of Macular hole
the closure rate of Macular hole
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start25 Jan 2016
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Macula 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
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojie Hu, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584062
- Sponsor's protocol ID
- HBJ 151617
- Status last verified
- Jun 2018
- First submitted
- 9 Oct 2015
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Eye Hospital of Tianjin Medical University
- ClinicalTrials.gov ID
- NCT02584062
- Acronym / sponsor ID
- HBJ 151617
- Conditions
- Idiopathic Macula Hole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 22 Oct 2015 (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 observe the technologic application of no-touch fluid-air exchange in Surgery of Idiopathic Macula Hole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no-touch fluid-air exchange group | Experimental | Procedure: no-touch fluid-air exchange, Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponedAll patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will not touch the macular area,especially the area of the macular hole and investigator will not have the fluid-air exchange of the macular area. |
| the tradional group | Experimental | Procedure: vitrectomy metrectomy and internal membrane peeling and gas tamponedAll patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will touch the macular area and investigator will have the fluid-air exchange. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients were diagnosed as having an idiopathic macular hole(IMH) by Optical Coherence Tomography(OCT).
Key exclusion criteria (2 listed)
- Myopia of >6 diopters
- Ocular trauma and other systematic or ocular issues associated with IMHs，such as the other macula disease, for example the degeneration of macula.
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 |
|---|---|---|
| no-touch fluid-air exchangeAlso: vitrectomy metrectomy and internal membrane peeling and gas tamponed | Procedure or surgery | no-touch fluid-air exchange group |
| vitrectomy metrectomy and internal membrane peeling and gas tamponed | Procedure or surgery | no-touch fluid-air exchange group, the tradional group |
Primary outcome
the closure rate of Macular hole
Time frame: one month
the closure rate of macular hole through OCT
the closure rate of Macular hole
Time frame: three month
the closure rate of Macular hole
the closure rate of Macular hole
Time frame: six month
the closure rate of Macular hole
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 19 Jun 2018.
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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 no-touch fluid-air exchange and vitrectomy metrectomy and internal membrane peeling and gas tamponed in people with Idiopathic Macula Hole, run by Tianjin Medical University Eye Hospital at 1 site 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 1 inclusion and 2 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 19 Jun 2018. 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 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?
the closure rate of Macular hole (time frame: one month). The study lists 3 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 19 Jun 2018.