Idiopathic Macular HolePhase 4NCT02905409
Study of Surgery in Patients With Idiopathic Macular Hole
A Phase 4 study testing ILM peeling surgery in people with Idiopathic Macular Hole and Surgery, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Idiopathic Macular Hole, Surgery
- 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
- 228 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2016to 30 Jun 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with IMH
- patients signed the 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
Minwei Zhao, M.D, 13801057408, dr_mingweizhao@163.com
Youxin Chen, M.D
About this study
Official title: A Randomized, Double-masked, Multicenter, Controlled Study of Effects of Internal Membrane Peeling Surgery in Patients With Idiopathic Macular Hole Measured by Optical Coherence Tomography.
The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.
Read the detailed description
The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.
- Conditions
- Idiopathic Macular Hole, Surgery
- Being tested
- ILM peeling surgery
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 IMH (idiopathic macular hole)
| Study group | Role | What they receive |
|---|---|---|
| 4PD diameter of ILM peeling in surgery | Active comparator | Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 4PD (papillary diameter) group, patients were given 4PD diameter of ILM (internal limiting membrane) peeling in surgery. Receives: Procedure: ILM peeling surgery |
| 2PD diameter of ILM peeling in surgery | Experimental | Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 2PD (papillary diameter) group, patients were given 2PD diameter of ILM (internal limiting membrane) 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
The anatomical outcomes were defined as good closure and poor closure.
Measured: 6 months
Change of anatomical closure grades in OCT
The anatomical outcomes were defined as good closure and poor closure.
Measured: 1 month, 3 months, 6 months, 1 year
Secondary outcomes (1)
Change from baseline in BCVA (best corrected visual acuity).
BCVA were measured by ETDRS chart.
Measured: 1 month, 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 posted19 Sep 2016 (estimated)
- Study start31 Aug 2016
- Primary completion31 Jan 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital, Beijing Hospital, Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Mingwei Zhao, Peking University People's Hospital
- Investigators
- Mingwei Zhao, M.D, Study director, Peking University People's HospitalHong Dai, M.D, Principal investigator, Peking Union Medical CollegeWenbin Wei, M.D, Principal investigator, Beijing Tongren Hospital of Capital Medical UniversityYouxin Chen, M.D, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905409
- Sponsor's protocol ID
- ILMIMH-CHINA
- Status last verified
- Dec 2019
- First submitted
- 2 Sep 2016
- Last updated
- 30 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Multicenter, Controlled Study of Effects of Internal Membrane Peeling Surgery in Patients With Idiopathic Macular Hole Measured by Optical Coherence Tomography.
- ClinicalTrials.gov ID
- NCT02905409
- Acronym / sponsor ID
- ILMIMH-CHINA
- Conditions
- Idiopathic Macular Hole, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Beijing Hospital, Peking Union Medical College Hospital
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 Sep 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 peeling with distinct diameters after macular hole surgery on anatomical closure grades.
Detailed description
The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4PD diameter of ILM peeling in surgery | Active comparator | Procedure: ILM peeling surgeryPatients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 4PD (papillary diameter) group, patients were given 4PD diameter of ILM (internal limiting membrane) peeling in surgery. |
| 2PD diameter of ILM peeling in surgery | Experimental | Procedure: ILM peeling surgeryPatients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 2PD (papillary diameter) group, patients were given 2PD diameter of ILM (internal limiting membrane) peeling in surgery. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with IMH
- patients signed the 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 IMH (idiopathic macular hole) | 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: 6 months
The anatomical outcomes were defined as good closure and poor closure.
Change of anatomical closure grades in OCT
Time frame: 1 month, 3 months, 6 months, 1 year
The anatomical outcomes were defined as good closure and poor closure.
1 secondary outcome
Change from baseline in BCVA (best corrected visual acuity).
Time frame: 1 month, 3 months, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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.
Mingwei Zhao, M.D study director
Peking University People's Hospital
Hong Dai, M.D principal investigator
Peking Union Medical College
Wenbin Wei, M.D principal investigator
Beijing Tongren Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ILM peeling surgery in people with Idiopathic Macular Hole and Surgery, run by Peking University People's 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 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: status not confirmed, as of the sponsor's last update on 30 Dec 2019. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingwei Zhao, M.D (13801057408, dr_mingweizhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical closure grades in OCT (time frame: 6 months). The study lists 2 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 30 Dec 2019.