Macular HolesNCT03805763
Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
A study testing Large extent of ILM Peeling and Small extent of ILM Peeling in people with Macular Holes, run by Wenzhou Medical University.
Trial summary
Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macular Holes
- What is being tested?
- Large extent of ILM Peeling and Small extent of ILM Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 31 Jan 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clear diagnosis of macular hole;
- The minimum diameter of the macular hole is >400 μm;
- Without serious systemic disease that make patients can not be operated;
Who cannot join
- suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
- opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
- eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
- traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
- having a history of vitrectomy surgery;
- glaucoma in stage of preclinical, severe stenosis or closure;
Trial locations and contacts
No sites are listed yet.
About this study
Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole
- Conditions
- Macular Holes
- Being tested
- Large extent of ILM Peeling, Small extent of ILM Peeling
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large extent of ILM PeelingProcedure or surgery
The extent of ILM peeling is 4DD
Small extent of ILM PeelingProcedure or surgery
The extent of ILM peeling is 2DD
| Study group | Role | What they receive |
|---|---|---|
| Large extent of ILM Peeling | Experimental | Extent of ILM peeling is 4DD and the ILM flap is inserted Receives: Procedure: Large extent of ILM Peeling |
| Small extent of ILM Peeling | Experimental | Extent of ILM peeling is 2DD and the ILM flap is inserted Receives: Procedure: Small extent of ILM Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condition of postoperative healing of macular holes
postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
Measured: 1 year
Mean change from baseline in best-corrected visual acuity (BCVA)
Assessed using the ETDRS protocol
Measured: 1 year
change from baseline in foveal avascular zone (FAZ) areas and diameter
Assessed on AngioOCT
Measured: 1 year
change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
Assessed on AngioOCT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangtian Zhou, Wenzhou Medical University
- Investigators
- Zongduan Zhang, M.D,PhD, Principal investigator, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805763
- Sponsor's protocol ID
- ZZD-Macular Hole
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
- ClinicalTrials.gov ID
- NCT03805763
- Acronym / sponsor ID
- ZZD-Macular Hole
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 16 Jan 2019 (actual)
- 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.
Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large extent of ILM Peeling | Experimental | Procedure: Large extent of ILM PeelingExtent of ILM peeling is 4DD and the ILM flap is inserted |
| Small extent of ILM Peeling | Experimental | Procedure: Small extent of ILM PeelingExtent of ILM peeling is 2DD and the ILM flap is inserted |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clear diagnosis of macular hole;
- The minimum diameter of the macular hole is >400 μm;
- Without serious systemic disease that make patients can not be operated;
Key exclusion criteria (6 listed)
- suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
- opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
- eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
- traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
- having a history of 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 |
|---|---|---|
| Large extent of ILM PeelingThe extent of ILM peeling is 4DD | Procedure or surgery | Large extent of ILM Peeling |
| Small extent of ILM PeelingThe extent of ILM peeling is 2DD | Procedure or surgery | Small extent of ILM Peeling |
Primary outcome
Condition of postoperative healing of macular holes
Time frame: 1 year
postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
Mean change from baseline in best-corrected visual acuity (BCVA)
Time frame: 1 year
Assessed using the ETDRS protocol
change from baseline in foveal avascular zone (FAZ) areas and diameter
Time frame: 1 year
Assessed on AngioOCT
change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
Time frame: 1 year
Assessed on AngioOCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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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.
Zongduan Zhang, M.D,PhD principal investigator
The Eye Hospital of Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Large extent of ILM Peeling and Small extent of ILM Peeling in people with Macular Holes, run by Wenzhou Medical University.
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: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zongduan Zhang, M.D,PhD (+86 13587604949, zzduan@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condition of postoperative healing of macular holes (time frame: 1 year). The study lists 4 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 16 Jan 2019.