Macular HolesNCT05396209
To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.
A study testing Hydrated Amniotic Membrane Plug, ILM filling and Conventional ILM peeling in people with Macular Holes, run by Oriental Neurosurgery Evidence-Based-Study Team at 1 site in China.
Trial summary
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 3 different techniques for the closure of the refractory macular holes (MH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Holes
- What is being tested?
- Hydrated Amniotic Membrane Plug, ILM filling and Conventional ILM peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 15 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic macular hole was defined as macular hole diameter (with no history of secondary macular hole) larger than 800μm in minimum linear diameter ;
- Patients with an idiopathic macular hole submitted to pars plana vitrectomy with internal limiting membrane peeling treatment without closing it and macular hole diameter larger than 200μm.
- Patients who meet any of 1/2 and signed informed consent can be included. Note: if both eyes of the subject meet the inclusion criteria, the investigator decides which eye should be included.
Who cannot join
- idiopathic macular hole diameter less than 800μm in minimum linear diameter;
- Macular hole caused by trauma and laser;
- Macular holes secondary to another vitreoretinal diseases;
- Macular hole of pathological myopia (axial length ≥26.0mm and diopter ≥6.00D，posterior scleral staphyloma，the atrophic choroid and retina with scleral exposure);
- Known to be allergic to amniotic membrane.
- Patients with any of the following eye diseases:
Show all 12Show fewer
- Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc);
- Macular hole of other causes (secondary)；
- History of vitreoretinal surgery for a condition other than the idiopathic macular hole (retinal detachment, vitreous hemorrhage);
- Patients with any of the following eye conditions:
- Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)；
- Patients with ocular surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Qihua Wang, MD, 86-10-18601180961, wqha01696@btch.edu.cn
Hua Yan, MD, PhD, 86-22-60817010, zyyyanhua@tmu.edu.cn
About this study
Official title: Multicenter Case Control Clinical Trials to Compare the Healing Process of Refractory Macular Hole With Different Surgical Techniques
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 3 different techniques for the closure of the refractory macular holes (MH).
Read the detailed description
The aim of the study is to evaluate the therapeutic efficacy of Hydrated Amniotic Membrane in promoting closure of refractory macular holes.
The Hydrated Amniotic Membrane has been used in some cases as an adjunct in the macular holes closure and as a substrate for cell growth and improvement of visual acuity. Hydrated Amniotic Membrane is supposed to promote epithelialization and have anti-fibrotic, anti-inflammatory properties.
In the present study, the patients who meet the inclusion criteria will be randomized and undergo pars plana vitrectomy surgery with peeling of the ILM and a fragment of the ILM itself or an amniotic membrane plug will be put in place.
The patients included in the study will undergo a complete eye examination, including corrected Visual Acuity measurement (BCVA), performing the Optical Coherence Tomography (OCT) and/or microperimetry, multifocal electroretinogram (mfERG) in the pre-operative. Patients will undergo surgery after complementary exams and adequate pre-anesthetic evaluation.
Patients will be evaluated on the 1st and 7th postoperative days and at 1, 3, and 6 months after surgery. The patient will undergo a complete eye examination and postoperative follow-up as described above, and during visits on the 1st and 7th day, and in the 1st, 3th and 6th month of the postoperative period, BCVA and OCT will be performed and/or the microperimetry, multifocal electroretinogram (mfERG) will be performed in the 1st, 3th and 6th postoperative month for evaluation and monitoring of anatomical and functional responses, respectively.
- Conditions
- Macular Holes
- Being tested
- Hydrated Amniotic Membrane Plug, ILM filling, Conventional 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.
Hydrated Amniotic Membrane PlugProcedure or surgery
Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole
ILM fillingProcedure or surgery
The ILM filling technique - Rossi et al show that ILM filling technique was more efficacious in closing full-thickness macular holes larger than 630μm, in which the free ILM after peeling is plug into the area of the macular hole
Conventional ILM peelingProcedure or surgery
Peeling with complete removal of the internal limiting membrane within the vascular arch
| Study group | Role | What they receive |
|---|---|---|
| Hydrated Amniotic Membrane Plug | Active comparator | Patients suffering from refractory macular holes as documented by spectral-domain OCT will undergo pars plan vitrectomy with Hydrated Amniotic Membrane insertion into the macular hole. Receives: Procedure: Hydrated Amniotic Membrane Plug |
| ILM filling | Active comparator | The ILM filling technique, in which free ILM is plug into the macular hole area Receives: Procedure: ILM filling |
| Conventional ILM peeling | Active comparator | Peeling with complete removal of the internal limiting membrane within the vascular arch Receives: Procedure: Conventional ILM peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anatomic closure
Rate of anatomic macular hole closure in the OCT at month 6
Measured: Month 6 post operative
Reconstruction of the foveal layered retinal structure change
Change in the reconstruction of the foveal layered retinal structure by OCT at 1, 3, and 6 months
Measured: Month 1, 3, 6 post-operative
Secondary outcomes (3)
amniotic membrane dislocation
conform amniotic membrane dislocation in the OCT and/or binocular indirect ophthalmoscope at day 1 and 7
Measured: DAY 1,7 post operative
BCVA change
change in the BCVA at Preoperative,1, 3, and 6 months
Measured: Time Frame: Preoperative,Month 1, 3, 6 post operative
Retinal capillary plexus density change
change in the retinal capillary plexus density with OCT-A at Preoperative,1, 3, and 6 months
Measured: Preoperative,Month 1, 3, 6 post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion15 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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hua Yan, MD,PhD, Principal investigator, Ophthalmology of Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396209
- Sponsor's protocol ID
- AMMH2022
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Case Control Clinical Trials to Compare the Healing Process of Refractory Macular Hole With Different Surgical Techniques
- ClinicalTrials.gov ID
- NCT05396209
- Acronym / sponsor ID
- AMMH2022
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study TeamUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 31 May 2022 (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.
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 3 different techniques for the closure of the refractory macular holes (MH).
Detailed description
The aim of the study is to evaluate the therapeutic efficacy of Hydrated Amniotic Membrane in promoting closure of refractory macular holes.
The Hydrated Amniotic Membrane has been used in some cases as an adjunct in the macular holes closure and as a substrate for cell growth and improvement of visual acuity. Hydrated Amniotic Membrane is supposed to promote epithelialization and have anti-fibrotic, anti-inflammatory properties.
In the present study, the patients who meet the inclusion criteria will be randomized and undergo pars plana vitrectomy surgery with peeling of the ILM and a fragment of the ILM itself or an amniotic membrane plug will be put in place.
The patients included in the study will undergo a complete eye examination, including corrected Visual Acuity measurement (BCVA), performing the Optical Coherence Tomography (OCT) and/or microperimetry, multifocal electroretinogram (mfERG) in the pre-operative. Patients will undergo surgery after complementary exams and adequate pre-anesthetic evaluation.
Patients will be evaluated on the 1st and 7th postoperative days and at 1, 3, and 6 months after surgery. The patient will undergo a complete eye examination and postoperative follow-up as described above, and during visits on the 1st and 7th day, and in the 1st, 3th and 6th month of the postoperative period, BCVA and OCT will be performed and/or the microperimetry, multifocal electroretinogram (mfERG) will be performed in the 1st, 3th and 6th postoperative month for evaluation and monitoring of anatomical and functional responses, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrated Amniotic Membrane Plug | Active comparator | Procedure: Hydrated Amniotic Membrane PlugPatients suffering from refractory macular holes as documented by spectral-domain OCT will undergo pars plan vitrectomy with Hydrated Amniotic Membrane insertion into the macular hole. |
| ILM filling | Active comparator | Procedure: ILM fillingThe ILM filling technique, in which free ILM is plug into the macular hole area |
| Conventional ILM peeling | Active comparator | Procedure: Conventional ILM peelingPeeling with complete removal of the internal limiting membrane within the vascular arch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- idiopathic macular hole was defined as macular hole diameter (with no history of secondary macular hole) larger than 800μm in minimum linear diameter ;
- Patients with an idiopathic macular hole submitted to pars plana vitrectomy with internal limiting membrane peeling treatment without closing it and macular hole diameter larger than 200μm.
- Patients who meet any of 1/2 and signed informed consent can be included. Note: if both eyes of the subject meet the inclusion criteria, the investigator decides which eye should be included.
Key exclusion criteria (12 listed)
- idiopathic macular hole diameter less than 800μm in minimum linear diameter;
- Macular hole caused by trauma and laser;
- Macular holes secondary to another vitreoretinal diseases;
- Macular hole of pathological myopia (axial length ≥26.0mm and diopter ≥6.00D，posterior scleral staphyloma，the atrophic choroid and retina with scleral exposure);
- Known to be allergic to amniotic membrane.
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 |
|---|---|---|
| Hydrated Amniotic Membrane PlugUsing Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole | Procedure or surgery | Hydrated Amniotic Membrane Plug |
| ILM fillingThe ILM filling technique - Rossi et al show that ILM filling technique was more efficacious in closing full-thickness macular holes larger than 630μm, in which the free ILM after peeling is plug into the area of the macular hole | Procedure or surgery | ILM filling |
| Conventional ILM peelingPeeling with complete removal of the internal limiting membrane within the vascular arch | Procedure or surgery | Conventional ILM peeling |
Primary outcome
Rate of Anatomic closure
Time frame: Month 6 post operative
Rate of anatomic macular hole closure in the OCT at month 6
Reconstruction of the foveal layered retinal structure change
Time frame: Month 1, 3, 6 post-operative
Change in the reconstruction of the foveal layered retinal structure by OCT at 1, 3, and 6 months
3 secondary outcomes
amniotic membrane dislocation
Time frame: DAY 1,7 post operative
BCVA change
Time frame: Time Frame: Preoperative,Month 1, 3, 6 post operative
Retinal capillary plexus density change
Time frame: Preoperative,Month 1, 3, 6 post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Hua Yan, MD,PhD principal investigator
Ophthalmology of Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrated Amniotic Membrane Plug, ILM filling and Conventional ILM peeling in people with Macular Holes, run by Oriental Neurosurgery Evidence-Based-Study Team 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 12 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 31 May 2022. 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 Qihua Wang, MD (86-10-18601180961, wqha01696@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Anatomic closure (time frame: Month 6 post operative). 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 31 May 2022.