Macular HolesNCT06063005
Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole
A study testing Translocation ILM Flap and ILM Peeling in people with Macular Holes, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The main objective of this study is to evaluate the therapeutic effectiveness of the internal limiting membrane (ILM) peeling and translocation surgery compared to the conventional surgical approach for treating large idiopathic macular hole (IMH) through a well-designed prospective randomized controlled clinical… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Macular Holes
- What is being tested?
- Translocation ILM Flap and ILM Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2025
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time.
- Participants diagnosed with idiopathic macular hole (IMH).
- Based on OCT scans, the minimum horizontal diameter of the macular hole is >500 and <900 µm.
- Participants with an axial length <26.0mm and a myopic degree lower than 6D.
- For participants with bilateral macular holes, the eye with a larger hole diameter will be included.
Who cannot join
- Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment;
- Patients with high myopia (axial length ≥ 26.0mm and myopia exceeding 6D);
- Patients with a history of ocular trauma or retinal laser treatment;
- Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia;
- Patients with contraindications to vitrectomy;
- Patients with severe or unstable systemic diseases;
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- Patients with a fasting blood glucose level ≥ 9mmol/L before surgery;
- Patients who participated in other clinical trials involving drugs or medical devices within 30 days prior to screening;
- Patients with a history of intraocular surgery within 3 months prior to screening;
- Patients with reduced visual function or vision in the contralateral eye as determined by the investigator;
- Patients who are not considered suitable for enrollment by the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200000
Peiquan Zhao, Ph.D., +86 13311620396, zhaopeiquan@126.com
About this study
The main objective of this study is to evaluate the therapeutic effectiveness of the internal limiting membrane (ILM) peeling and translocation surgery compared to the conventional surgical approach for treating large idiopathic macular hole (IMH) through a well-designed prospective randomized controlled clinical trial. This study aims to compare the new surgical approach to the conventional approach in terms of improving visual function, promoting macular retinal anatomical healing, and enhancing patients' quality of life. By conducting this prospective clinical trial, establishing a database, and generating clinical reports and evidence-based medicine on the therapeutic efficacy of the ILM peeling and translocation surgery for large IMH.
- Conditions
- Macular Holes
- Being tested
- Translocation ILM Flap, 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.
Translocation ILM FlapProcedure or surgery
After vitrectomy, the ILM was dissected from the macula to the vascular arch, and the retina in the fissure area was fully released to make an MH-centered, approximately 2DD-square, ILM flap with a tip (approximately 500μm wide) above; the ILM flap was transposed approximately 25-30 degrees along the tip to the inferior temporal area with the assistance of heavy water, and a total of 1ml of perfluorodecalin fluid (heavy water) was injected to cover the MH area with the ILM flap, and the original ILM defect area corresponding to the MH was transposed to the outside of the MH. The heavy water is replaced by liquid/gas exchange. Ophthalmic 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen as the postoperative intraocular filling.
ILM PeelingProcedure or surgery
After vitrectomy, internal limiting membrane peeling up to the vascular arcade, thorough loosening of the macular hole area of the retina, and fluid/gas exchange. An eye-specific 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen for intraocular tamponade after the operation.
| Study group | Role | What they receive |
|---|---|---|
| Translocation | Experimental | Not described Receives: Procedure: Translocation ILM Flap |
| Peeling | Active comparator | Not described Receives: Procedure: ILM Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
The best corrected visual acuity indicates the best visual acuity with proper refractive correction.
Measured: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
Secondary outcomes (1)
Closure rate
MH closure is mainly reflected in the outer layer of continuity closure shown on OCT.
Measured: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Jul 2022
- Primary completion1 May 2025 (estimated)
- Study completion30 Jun 2025 (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.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Principal investigator, Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Peiquan Zhao, Dr., Study chair, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063005
- Sponsor's protocol ID
- XH-22-084
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole
- ClinicalTrials.gov ID
- NCT06063005
- Acronym / sponsor ID
- XH-22-084
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Oct 2023 (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.
The main objective of this study is to evaluate the therapeutic effectiveness of the internal limiting membrane (ILM) peeling and translocation surgery compared to the conventional surgical approach for treating large idiopathic macular hole (IMH) through a well-designed prospective randomized controlled clinical trial. This study aims to compare the new surgical approach to the conventional approach in terms of improving visual function, promoting macular retinal anatomical healing, and enhancing patients' quality of life. By conducting this prospective clinical trial, establishing a database, and generating clinical reports and evidence-based medicine on the therapeutic efficacy of the ILM peeling and translocation surgery for large IMH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Translocation | Experimental | Procedure: Translocation ILM Flap |
| Peeling | Active comparator | Procedure: ILM Peeling |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time.
- Participants diagnosed with idiopathic macular hole (IMH).
- Based on OCT scans, the minimum horizontal diameter of the macular hole is >500 and <900 µm.
- Participants with an axial length <26.0mm and a myopic degree lower than 6D.
- For participants with bilateral macular holes, the eye with a larger hole diameter will be included.
Key exclusion criteria (11 listed)
- Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment;
- Patients with high myopia (axial length ≥ 26.0mm and myopia exceeding 6D);
- Patients with a history of ocular trauma or retinal laser treatment;
- Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia;
- Patients with contraindications to vitrectomy;
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 |
|---|---|---|
| Translocation ILM FlapAfter vitrectomy, the ILM was dissected from the macula to the vascular arch, and the retina in the fissure area was fully released to make an MH-centered, approximately 2DD-square, ILM flap with a tip (approximately 500μm wide) above; the ILM flap was transposed approximately 25-30 degrees along the tip to the inferior temporal area with the assistance of heavy water, and a total of 1ml of perfluorodecalin fluid (heavy water) was injected to cover the MH area with the ILM flap, and the original ILM defect area corresponding to the MH was transposed to the outside of the MH. The heavy water is replaced by liquid/gas exchange. Ophthalmic 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen as the postoperative intraocular filling. | Procedure or surgery | Translocation |
| ILM PeelingAfter vitrectomy, internal limiting membrane peeling up to the vascular arcade, thorough loosening of the macular hole area of the retina, and fluid/gas exchange. An eye-specific 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen for intraocular tamponade after the operation. | Procedure or surgery | Peeling |
Primary outcome
Best Corrected Visual Acuity
Time frame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
The best corrected visual acuity indicates the best visual acuity with proper refractive correction.
1 secondary outcome
Closure rate
Time frame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Peiquan Zhao, Dr. study chair
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Translocation ILM Flap and ILM Peeling in people with Macular Holes, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 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 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peiquan Zhao, Dr. (0086 13311620396, zhaopeiquan@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation). 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 Oct 2023.