UnknownNot Applicable

To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.

China80 participantsStarted 2022-06-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

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 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);

What they're measuring

Rate of Anatomic closure

Timeframe: Month 6 post operative

Reconstruction of the foveal layered retinal structure change

Timeframe: Month 1, 3, 6 post-operative

Trial details

NCT IDNCT05396209

SponsorOriental Neurosurgery Evidence-Based-Study Team

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-15

Contact for this trial

Qihua Wang, MD

86-10-18601180961 wqha01696@btch.edu.cn

View on ClinicalTrials.gov More Macular Holes trials