To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.
Macular Holes
About this trial
This is an interventional treatment trial for Macular Holes
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
- 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.
Sites / Locations
- Tianjin Medical University General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Hydrated Amniotic Membrane Plug
ILM filling
Conventional ILM peeling
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.
The ILM filling technique, in which free ILM is plug into the macular hole area
Peeling with complete removal of the internal limiting membrane within the vascular arch