Status:
UNKNOWN
To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.
Lead Sponsor:
Oriental Neurosurgery Evidence-Based-Study Team
Conditions:
Macular Holes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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).
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05396209
Start Date
June 1 2022
End Date
June 15 2025
Last Update
May 31 2022
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052