Macular HolePhase 4NCT02930369
Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery
A Phase 4 study testing ILM peeling surgery in people with Macular Hole, run by Peking University People's Hospital.
Trial summary
The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT). Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Macular Hole
- What is being tested?
- ILM peeling surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2016
- Phase
- Phase 4
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with IMH
- patients signed the informed consent form (ICF)
- patients with course of IMH less than 3 years
Who cannot join
- patients with hyper myopia
- patients with traumatic macular hole
- accompanied or secondary of other fundus disease
- open or reopen after receiving MH surgery
- patients with retinal detachment
- received vitrectomy due to other diseases
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- glaucoma cannot be controled by medication
- patients with other retinal or choroidal disease that may affect VA
- poor patients compliance
- poor condition that cannot undertake the surgery
- dioptric media opacities which make it difficult to exam fundus or measure on OCT
About this study
Official title: A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole
The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).
- Conditions
- Macular Hole
- Being tested
- ILM peeling surgery
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILM peeling surgeryProcedure or surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)
| Study group | Role | What they receive |
|---|---|---|
| 4PD diameter of ILM peeling in surgery | Active comparator | patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery Receives: Procedure: ILM peeling surgery |
| 2PD diameter of ILM peeling in surgery | Experimental | patients in this group was given 2PD diameter of ILM peeling in surgery Receives: Procedure: ILM peeling surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical closure grades in OCT
Measured: 1 year
Secondary outcomes (2)
Change of anatomical closure grades in OCT
Measured: 3 months, 6 months, 1 year
Change from baseline in BCVA (best corrected visual acuity)
Measured: 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HoleStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingwei Zhao, Peking University People's Hospital
- Investigators
- Mingwei Zhao, M.D, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930369
- Sponsor's protocol ID
- DAILMP-CHINA
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole
- ClinicalTrials.gov ID
- NCT02930369
- Acronym / sponsor ID
- DAILMP-CHINA
- Conditions
- Macular Hole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Oct 2016 (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 effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4PD diameter of ILM peeling in surgery | Active comparator | Procedure: ILM peeling surgerypatients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery |
| 2PD diameter of ILM peeling in surgery | Experimental | Procedure: ILM peeling surgerypatients in this group was given 2PD diameter of ILM peeling in surgery |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with IMH
- patients signed the informed consent form (ICF)
- patients with course of IMH less than 3 years
Key exclusion criteria (11 listed)
- patients with hyper myopia
- patients with traumatic macular hole
- accompanied or secondary of other fundus disease
- open or reopen after receiving MH surgery
- patients with retinal detachment
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 |
|---|---|---|
| ILM peeling surgery4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH) | Procedure or surgery | 2PD diameter of ILM peeling in surgery, 4PD diameter of ILM peeling in surgery |
Primary outcome
Anatomical closure grades in OCT
Time frame: 1 year
2 secondary outcomes
Change of anatomical closure grades in OCT
Time frame: 3 months, 6 months, 1 year
Change from baseline in BCVA (best corrected visual acuity)
Time frame: 3 months, 6 months, 1 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 12 Oct 2016.
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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.
Mingwei Zhao, M.D study director
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ILM peeling surgery in people with Macular Hole, run by Peking University People's Hospital.
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 11 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 12 Oct 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 grades in OCT (time frame: 1 year). 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 12 Oct 2016.