Status:
ACTIVE_NOT_RECRUITING
The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study
Lead Sponsor:
Hospital Oftalmologico de Sorocaba
Conditions:
Macular Holes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane...
Detailed Description
This study will evaluate functional outcomes through microperimetry in patients undergoing macular hole surgery. It will focus on patients with macular holes ≥600 microns, as well as those with holes ...
Eligibility Criteria
Inclusion
- Patients with a macula hole that falls into the two categories below:
- Patients with idiopathic macular hole (with no history of secondary macular hole) ≥ 600 microns (measured using optical coherence tomography)
- Patients with an idiopathic macular hole submitted to conventional treatment without closing it (of any size).
- History of the disease less than 18 months
- Aged over 18 years old
- Visual acuity less than 20/32
Exclusion
- History of any previous macular disease other than idiopathic macular hole
- Macular hole of other causes (secondary)
- Patients with diabetic retinopathy or other retinal vascular diseases
- Eyes subjected to intravitreal injection of any medication
- Visual acuity \<20/400 of any retinal cause in the contralateral eye or absence of the globe \*Aged under 50 years old
- Cataract and anti-glaucoma surgery less than 3 months before the study
- Glaucoma with optic nerve excavation \> 0.7 in the studied eye
- Intraocular pressure \> 24 mmHg with the use of maximum medication in the studied eye
- History of vitreoretinal surgery for a condition other than the idiopathic macular hole (retinal detachment, vitreous hemorrhage)
- History of retinal detachment of any etiology
- A patient who manifests himself not being able to perform the head position in the postoperative period
- A patient with active anterior or posterior uveitis
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04904679
Start Date
June 26 2020
End Date
December 31 2025
Last Update
May 6 2025
Active Locations (2)
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1
Hospital Oftalmologico de Sorocaba/ Banco de Olhos de Sorocaba
Sorocaba, São Paulo, Brazil, 18031060
2
Sorocaba Eye's Hospital
Sorocaba, São Paulo, Brazil, 18031060