Macular HolesNCT06359548
PEELED INTERNAL LIMITING MEMBRANE REPOSITION
A study testing Peeled ILM Reposition 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
Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Macular Holes
- What is being tested?
- Peeled ILM Reposition and ILM Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography.
- Age ranges from 50 to 80 years.
- Do not participate in other clinical studies.
- Agree to sign an informed consent form with good compliance.
Who cannot join
- Traumatic macular hole.
- Combined with serious epiretinal membrane.
- Combined with diabetic retinopathy, hypertensive retinopathy.
- Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
- Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm.
- History of intraocular surgery.
- Presence of staphyloma.
- Other ocular diseases that influence macular microstructure or visual function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School
Shanghai
Tian Tian, Dr.
About this study
Official title: PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial
Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.
- Conditions
- Macular Holes
- Being tested
- Peeled ILM Reposition, 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.
Peeled ILM RepositionProcedure or surgery
Also called ILM Flap reposition, ILM Flap covering
The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc) at a point away from the center of MH around one disc diameter in inferior quadrant of macular area. First, a horizontal ILM strip was peeled off with a width approximately 1.5 to 2.5 disc diameter. Then, the edge of the horizontal ILM strip was grasped and peeled from inferior to superior area continuously.Then the "ILM roll" was flattened back to peeled area assisted with approximately 1.0 mL of PFO (Perfluoron, Alcon Laboratories, Inc). The position of the fixed ILM flap was adjusted under PFO bubble using flute needle or forceps if required.
ILM PeelingProcedure or surgery
The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc). The strand of ILM was peeled off radially from the foveal center to the vascular arcade. As a result, a round-shaped, 2.5-disk diameter to 3.5-disk diameter ILM-peeled area was created.
| Study group | Role | What they receive |
|---|---|---|
| Reposition Group | Experimental | Peeled ILM Reposition Receives: Procedure: Peeled ILM Reposition |
| Peeling Group | Active comparator | ILM Peeling Receives: Procedure: ILM Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively
The change of BCVA from baseline to 6-month postoperatively
Measured: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Secondary outcomes (7)
The MH closure rate
The MH closure rate at 1-month postoperatively
Measured: 1-month postoperatively
The range of inner retinal dimpling
The range of inner retinal dimpling was measured by OCT (RTVueXR Avanti; Optovue Inc, Fremont, CA)
Measured: 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Postoperative retinal thickness
With the Thickness Map protocol of the OCT, the full retinal thickness (from ILM to retinal pigment epithelium), inner retinal thickness (from ILM to inner plexiform layer (IPL)), and outer retinal thickness (from IPL to retinal pigment epithelium) of the fovea, parafovea, and perifovea were recorded, respectively.
Measured: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
The fixation stability and sensitivity threshold
Measured by microperimetry (MAIA, CenterVue, Italy)
Measured: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
mfERG P1 wave density amplitudes
Measured by multifocal electroretinogram (mfERG, Espion, Diagnosys LLC, Cambridge, United Kingdom)
Measured: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
M-score values
Metamorphopsia score (M-score) measurement was performed using the M-chart (Inami Co, Tokyo, Japan)
Measured: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
NEI-VFQ-25 questionnaire scores
The scores obtain from National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25 questionnaire)
Measured: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionNov 2026 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tian Tian, MD，PhD, Principal investigator, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359548
- Sponsor's protocol ID
- XH-24-002
- Status last verified
- Jan 2024
- First submitted
- 29 Mar 2024
- Last updated
- 11 Apr 2024
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT06359548
- Acronym / sponsor ID
- XH-24-002
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Apr 2024 (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.
Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reposition Group | Experimental | Procedure: Peeled ILM RepositionPeeled ILM Reposition |
| Peeling Group | Active comparator | Procedure: ILM PeelingILM Peeling |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography.
- Age ranges from 50 to 80 years.
- Do not participate in other clinical studies.
- Agree to sign an informed consent form with good compliance.
Key exclusion criteria (8 listed)
- Traumatic macular hole.
- Combined with serious epiretinal membrane.
- Combined with diabetic retinopathy, hypertensive retinopathy.
- Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
- Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm.
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 |
|---|---|---|
| Peeled ILM RepositionAlso: ILM Flap reposition, ILM Flap coveringThe ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc) at a point away from the center of MH around one disc diameter in inferior quadrant of macular area. First, a horizontal ILM strip was peeled off with a width approximately 1.5 to 2.5 disc diameter. Then, the edge of the horizontal ILM strip was grasped and peeled from inferior to superior area continuously.Then the "ILM roll" was flattened back to peeled area assisted with approximately 1.0 mL of PFO (Perfluoron, Alcon Laboratories, Inc). The position of the fixed ILM flap was adjusted under PFO bubble using flute needle or forceps if required. | Procedure or surgery | Reposition Group |
| ILM PeelingThe ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc). The strand of ILM was peeled off radially from the foveal center to the vascular arcade. As a result, a round-shaped, 2.5-disk diameter to 3.5-disk diameter ILM-peeled area was created. | Procedure or surgery | Peeling Group |
Primary outcome
The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
The change of BCVA from baseline to 6-month postoperatively
7 secondary outcomes
The MH closure rate
Time frame: 1-month postoperatively
The range of inner retinal dimpling
Time frame: 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Postoperative retinal thickness
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
The fixation stability and sensitivity threshold
Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
mfERG P1 wave density amplitudes
Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
M-score values
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
NEI-VFQ-25 questionnaire scores
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Tian Tian, MD，PhD principal investigator
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peeled ILM Reposition 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Tian, MD，PhD (+8615216695095, tiantianoph@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively (time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,). 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 11 Apr 2024.