To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.
NCT ID: NCT05396209
Last Updated: 2022-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-06-01
2025-06-15
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hydrated Amniotic Membrane Plug
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.
Hydrated Amniotic Membrane Plug
Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole
ILM filling
The ILM filling technique, in which free ILM is plug into the macular hole area
ILM filling
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 peeling
Peeling with complete removal of the internal limiting membrane within the vascular arch
Conventional ILM peeling
Peeling with complete removal of the internal limiting membrane within the vascular arch
Interventions
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Hydrated Amniotic Membrane Plug
Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole
ILM filling
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 peeling
Peeling with complete removal of the internal limiting membrane within the vascular arch
Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
2. Macular hole caused by trauma and laser;
3. Macular holes secondary to another vitreoretinal diseases;
4. Macular hole of pathological myopia (axial length ≥26.0mm and diopter ≥6.00D，posterior scleral staphyloma，the atrophic choroid and retina with scleral exposure);
5. Known to be allergic to amniotic membrane.
Patients with any of the following eye diseases:
6. Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc);
7. Macular hole of other causes (secondary)；
8. 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:
9. Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)；
10. Patients with ocular surgery.
18 Years
ALL
No
Sponsors
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Oriental Neurosurgery Evidence-Based-Study Team
OTHER
Responsible Party
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Principal Investigators
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Hua Yan, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmology of Tianjin Medical University General Hospital
Locations
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qihua Wang, MD
Role: primary
Hua Yan, MD, PhD
Role: backup
Other Identifiers
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AMMH2022
Identifier Type: -
Identifier Source: org_study_id