Macular HoleILM MHNCT06685328
Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH
A study testing minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position and Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position in people with Macular Hole and Macular Hole Surgery, run by Jie Zhong at 1 site in China.
Trial summary
The purpose of this clinical trial is to compare the prognostic validity of two different surgical approaches: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position, versus conventional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole, Macular Hole Surgery, Idiopathic Macular Hole
- What is being tested?
- minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position and Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 30 Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with idiopathic macular hole and 250 μm ≤ aperture size ≤ 800 μm, with clinical diagnosis based on visual acuity testing, fundus photography, and swept optical coherence tomography/optical coherence tomography angiography (SS-OCT/OCTA)
- Age ≥18 years, gender not restricted
- 22 mm ≤ eye axis ≤ 26 mm
- Patients who can cooperate with accurate microperimetry testing
- Individuals who are able to follow up at the time specified by the researcher
Who cannot join
- Coexisting active eyelid or appendage infections
- Coexisting ocular pathology other than cataract that affects vision (e.g., retinal detachment or proliferative vitreoretinopathy; diabetic retinopathy; retinal vascular occlusion; uveitis; ocular tumors; glaucoma)
- patients who refused to be randomized
- Other relevant medical history such as cranial brain disease, systemic immune system disease, etc.
- Those who have received medical or surgical treatment other than myopia and cataract in the study eye within the previous 12 months
- Other patients who, in the opinion of the investigator, should be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study of Minimal Posterior Pole Vitrectomy and Fixing the Inverted Inner Limiting Membrane Flap with Sodium Hyaluronate Gel for Macular Hole
The purpose of this clinical trial is to compare the prognostic validity of two different surgical approaches: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position, versus conventional vitrectomy combined with ILM flap flap coverage with sterile air filling and postoperative prone position.
The main question it aims to answer is:
Read more
Whether patients with macular hole have the same or even better prognosis with minimal posterior pole vitrectomy combined with sodium hyaluronate gel covered flip ILM flap accompanied by balanced salt solution filling accompanied by postoperative supine position than with conventional macular hole surgery.
Participants will:
The control group undergoes conventional vitrectomy combined with internal limbal flap coverage accompanied by sterile air filling of the vitreous cavity and three days of postoperative surgery in strict supine position. The study group undergoes minimal posterior pole vitrectomy combined with sodium hyaluronate gel-assisted flap of the inner border membrane accompanied by 24 hours of postoperative surgical treatment in a non-strict supine position.
Participants of this study come to Sichuan Provincial People's Hospital for follow-up examinations at 1 day, 3 days, 1 week, 1 month, 3 months, and 6 months postoperatively in the 23rd clinic of the Sichuan Provincial People's Hospital for review of visual acuity, intraocular pressure, fundus photography, optical coherence tomography angiography, microfluidic field of view (at 6 months postoperatively), and slit-lamp examination.
Read the detailed description
Macular hole is a tissue defect that occurs from the inner limiting membrane of the retina to the photoreceptor layer in the macula, severely compromising the patient's central vision. Currently, the standard of care for macular holes is complete vitrectomy combined with stripping, plugging, or flipping of the inner limiting membrane to cover the macular hole, followed by tamponade with prolonged gas or filtered air. After surgery, patients are usually required to remain in a supine position for days to weeks, which is extremely stressful. Despite the effectiveness of current methods, there is still room for thought and improvement.
Given the potential drawbacks of the current mainstream surgery, one investigator developed a minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-assisted flip inner border flap technique for macular hole repair that eliminates the need for prolonged gas or filtered air tamponade and the need for patients to remain in the face-down position for long periods postoperatively. Primary healing was achieved in all postoperative macular holes. However, existing studies have small sample sizes and irregular follow-up times.
In this project, the researchers plan to investigate the prognostic effects of this minimal posterior pole vitrectomy combined with sodium hyaluronate gel-assisted flap with non-strict supine postoperative position for 24 hours and traditional vitrectomy combined with flap covering with sterile air-filled vitreous cavity and strict prone postoperative position for three days on the prognosis of macular holes, and to investigate the therapeutic effects of different surgical methods on macular holes and provide a new idea for the surgical treatment of macular holes. To provide new ideas for the surgical treatment of macular hole.
- Conditions
- Macular Hole, Macular Hole Surgery, Idiopathic Macular Hole, Macular Hole of Left Eye (Disorder), Macular Hole of Right Eye (Disorder)
- Being tested
- minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position, Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position
- Keywords
- macular hole, inner limiting membrane flap, sodium hyaluronate gel, minimal posterior pole vitrectomy
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine positionProcedure or surgery
Vitrectomy of the posterior pole within the vascular arch was performed by a standard 25G ciliary flattening three-way tract procedure, followed by injection of a small amount of tretinoin suspension (TA) to mark the posterior vitreous cortex, which was excised. The inner limiting membrane (ILM) of the macular surface was stained with indocyanine green (ICG, 2.5 mg/ml), and the ILM around the hole was peeled off, leaving a semicircular piece of ILM attached to the hole, and then the single ILM flap was folded and covered with MH. 0.2 to 0.3 mL of hyaluronic acid gel (Bausch \& Lomb, Iviz) was injected over the inverted ILM flap using perfluorocarbon liquid for complete coverage. The perfluorocarbon liquid was aspirated. Postoperatively, the patient was advised to remain in a non-emergent supine position for 24 hours.
Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone positionProcedure or surgery
A standard 25G ciliary flattening three-way tract procedure was taken to perform posterior and midperipheral vitrectomy, followed by injection of a small amount of tretinoin (TA) to label the posterior vitreous cortex and excision of the posterior vitreous cortex within the vascular arch. The ILM on the macular surface was stained with indocyanine green (ICG, 2.5 mg/ml), and the peripapillary ILM was peeled off with forceps, leaving a semicircular piece of ILM attached to the foramen ovale, and the individual ILM flaps were then turned over and covered with MH. Air-liquid exchange was then performed and subsequent surgery was routinely performed according to existing surgical concepts. Ultrasonic emulsification and IOL implantation were selectively performed depending on the extent of the cataract and the patient's surgical needs. Antibiotic ointment is applied at the end of the procedure. After surgery, patients were advised to remain in strict prone position for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| minimal posterior pole vitrectomy | Experimental | Patients undergo minimal posterior pole vitrectomy with tearing of the internal limiting membrane and its folding to cover the macular hole, injection of perfluorocarbon liquid to isolate the balanced salt solution, injection of sodium hyaluronate gel under the perfluorocarbon liquid to cover the folded internal limiting membrane, replacement of the perfluorocarbon liquid and filling of the vitreous cavity with the balanced salt solution and postoperative supine position for 24 hours. Receives: Procedure: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position |
| conventional vitrectomy | Other | Patient undergo conventional vitrectomy with tearing of the inner limiting membrane and flipping to cover the macular hole, gas-liquid exchange and sterile air to fill the vitreous cavity, keeping standard prone position for three days postoperatively. Receives: Procedure: Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative best corrected visual acuity
Testing patients' visual function through the visual acuity chart
Measured: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Secondary outcomes (6)
The time point at which best corrected visual acuity is achieved
Measured: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Anatomic closure rate at 6 months postoperatively
Evaluate the anatomical structure of the macular area through OCT/OCTA. Recording the proportion of achieving type 1 closure(1A: reconstruction of all retinal layers; 1B outer layer disruption; 1C inner layer disruption) and time point of achieving type 1 closure
Measured: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Postoperative cataract progression rates in two surgical modalities
If the patient have no or mild preoperative cataract, the researchers will observe the rate of postoperative cataract progression in both groups; if the patient have moderate to severe cataract, the researchers will perform cataract surgery at the same time as the macular hole surgery.
Measured: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Proportion of postoperative displacement of the internal limiting membrane in the two surgical modalities
Evaluate the anatomical structure of the macular area through OCT/OCTA
Measured: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Microperimetry changes: microperimetry at 6 months postoperatively
Assess macular sensitivity via microperimetry
Measured: 6 months after surgery
Incidence of adverse events
e.g., high intraocular pressure, retinal detachment, hemorrhage, cataract worsening, and infection
Measured: Within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
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.
- 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Zhong, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685328
- Sponsor's protocol ID
- 2024-598
- Acronym
- ILM MH
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Minimal Posterior Pole Vitrectomy and Fixing the Inverted Inner Limiting Membrane Flap with Sodium Hyaluronate Gel for Macular Hole
- ClinicalTrials.gov ID
- NCT06685328
- Acronym / sponsor ID
- ILM MH / 2024-598
- Conditions
- Macular Hole, Macular Hole Surgery, Idiopathic Macular Hole, Macular Hole of Left Eye (Disorder), Macular Hole of Right Eye (Disorder)
- Keywords
- macular hole, inner limiting membrane flap, sodium hyaluronate gel, minimal posterior pole vitrectomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Jie ZhongUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Nov 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.
The purpose of this clinical trial is to compare the prognostic validity of two different surgical approaches: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position, versus conventional vitrectomy combined with ILM flap flap coverage with sterile air filling and postoperative prone position.
The main question it aims to answer is:
Whether patients with macular hole have the same or even better prognosis with minimal posterior pole vitrectomy combined with sodium hyaluronate gel covered flip ILM flap accompanied by balanced salt solution filling accompanied by postoperative supine position than with conventional macular hole surgery.
Participants will:
The control group undergoes conventional vitrectomy combined with internal limbal flap coverage accompanied by sterile air filling of the vitreous cavity and three days of postoperative surgery in strict supine position. The study group undergoes minimal posterior pole vitrectomy combined with sodium hyaluronate gel-assisted flap of the inner border membrane accompanied by 24 hours of postoperative surgical treatment in a non-strict supine position.
Participants of this study come to Sichuan Provincial People's Hospital for follow-up examinations at 1 day, 3 days, 1 week, 1 month, 3 months, and 6 months postoperatively in the 23rd clinic of the Sichuan Provincial People's Hospital for review of visual acuity, intraocular pressure, fundus photography, optical coherence tomography angiography, microfluidic field of view (at 6 months postoperatively), and slit-lamp examination.
Detailed description
Macular hole is a tissue defect that occurs from the inner limiting membrane of the retina to the photoreceptor layer in the macula, severely compromising the patient's central vision. Currently, the standard of care for macular holes is complete vitrectomy combined with stripping, plugging, or flipping of the inner limiting membrane to cover the macular hole, followed by tamponade with prolonged gas or filtered air. After surgery, patients are usually required to remain in a supine position for days to weeks, which is extremely stressful. Despite the effectiveness of current methods, there is still room for thought and improvement.
Given the potential drawbacks of the current mainstream surgery, one investigator developed a minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-assisted flip inner border flap technique for macular hole repair that eliminates the need for prolonged gas or filtered air tamponade and the need for patients to remain in the face-down position for long periods postoperatively. Primary healing was achieved in all postoperative macular holes. However, existing studies have small sample sizes and irregular follow-up times.
In this project, the researchers plan to investigate the prognostic effects of this minimal posterior pole vitrectomy combined with sodium hyaluronate gel-assisted flap with non-strict supine postoperative position for 24 hours and traditional vitrectomy combined with flap covering with sterile air-filled vitreous cavity and strict prone postoperative position for three days on the prognosis of macular holes, and to investigate the therapeutic effects of different surgical methods on macular holes and provide a new idea for the surgical treatment of macular holes. To provide new ideas for the surgical treatment of macular hole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimal posterior pole vitrectomy | Experimental | Procedure: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine positionPatients undergo minimal posterior pole vitrectomy with tearing of the internal limiting membrane and its folding to cover the macular hole, injection of perfluorocarbon liquid to isolate the balanced salt solution, injection of sodium hyaluronate gel under the perfluorocarbon liquid to cover the folded internal limiting membrane, replacement of the perfluorocarbon liquid and filling of the vitreous cavity with the balanced salt solution and postoperative supine position for 24 hours. |
| conventional vitrectomy | Other | Procedure: Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone positionPatient undergo conventional vitrectomy with tearing of the inner limiting membrane and flipping to cover the macular hole, gas-liquid exchange and sterile air to fill the vitreous cavity, keeping standard prone position for three days postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with idiopathic macular hole and 250 μm ≤ aperture size ≤ 800 μm, with clinical diagnosis based on visual acuity testing, fundus photography, and swept optical coherence tomography/optical coherence tomography angiography (SS-OCT/OCTA)
- Age ≥18 years, gender not restricted
- 22 mm ≤ eye axis ≤ 26 mm
- Patients who can cooperate with accurate microperimetry testing
- Individuals who are able to follow up at the time specified by the researcher
Key exclusion criteria (6 listed)
- Coexisting active eyelid or appendage infections
- Coexisting ocular pathology other than cataract that affects vision (e.g., retinal detachment or proliferative vitreoretinopathy; diabetic retinopathy; retinal vascular occlusion; uveitis; ocular tumors; glaucoma)
- patients who refused to be randomized
- Other relevant medical history such as cranial brain disease, systemic immune system disease, etc.
- Those who have received medical or surgical treatment other than myopia and cataract in the study eye within the previous 12 months
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 |
|---|---|---|
| minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine positionVitrectomy of the posterior pole within the vascular arch was performed by a standard 25G ciliary flattening three-way tract procedure, followed by injection of a small amount of tretinoin suspension (TA) to mark the posterior vitreous cortex, which was excised. The inner limiting membrane (ILM) of the macular surface was stained with indocyanine green (ICG, 2.5 mg/ml), and the ILM around the hole was peeled off, leaving a semicircular piece of ILM attached to the hole, and then the single ILM flap was folded and covered with MH. 0.2 to 0.3 mL of hyaluronic acid gel (Bausch \& Lomb, Iviz) was injected over the inverted ILM flap using perfluorocarbon liquid for complete coverage. The perfluorocarbon liquid was aspirated. Postoperatively, the patient was advised to remain in a non-emergent supine position for 24 hours. | Procedure or surgery | minimal posterior pole vitrectomy |
| Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone positionA standard 25G ciliary flattening three-way tract procedure was taken to perform posterior and midperipheral vitrectomy, followed by injection of a small amount of tretinoin (TA) to label the posterior vitreous cortex and excision of the posterior vitreous cortex within the vascular arch. The ILM on the macular surface was stained with indocyanine green (ICG, 2.5 mg/ml), and the peripapillary ILM was peeled off with forceps, leaving a semicircular piece of ILM attached to the foramen ovale, and the individual ILM flaps were then turned over and covered with MH. Air-liquid exchange was then performed and subsequent surgery was routinely performed according to existing surgical concepts. Ultrasonic emulsification and IOL implantation were selectively performed depending on the extent of the cataract and the patient's surgical needs. Antibiotic ointment is applied at the end of the procedure. After surgery, patients were advised to remain in strict prone position for 3 days. | Procedure or surgery | conventional vitrectomy |
Primary outcome
postoperative best corrected visual acuity
Time frame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Testing patients' visual function through the visual acuity chart
6 secondary outcomes
The time point at which best corrected visual acuity is achieved
Time frame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Anatomic closure rate at 6 months postoperatively
Time frame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Postoperative cataract progression rates in two surgical modalities
Time frame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Proportion of postoperative displacement of the internal limiting membrane in the two surgical modalities
Time frame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Microperimetry changes: microperimetry at 6 months postoperatively
Time frame: 6 months after surgery
Incidence of adverse events
Time frame: Within 6 months after surgery
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 12 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position and Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position in people with Macular Hole and Macular Hole Surgery, run by Jie Zhong 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 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: enrolling by invitation, as of the sponsor's last update on 12 Nov 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?
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?
postoperative best corrected visual acuity (time frame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery). 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 Nov 2024.