Clinical trial NCT05396209: To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.
Official title: Multicenter Case Control Clinical Trials to Compare the Healing Process of Refractory Macular Hole With Different Surgical Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Holes
Lead sponsor: Oriental Neurosurgery Evidence-Based-Study Team
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. idiopathic macular hole was defined as macular hole diameter (with no history of secondary macular hole) larger than 800μm in minimum linear diameter ;
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.

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:

1. idiopathic macular hole diameter less than 800μm in minimum linear diameter;
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.

Primary outcomes:
measure: Rate of Anatomic closure
timeFrame: Month 6 post operative
measure: Reconstruction of the foveal layered retinal structure change
timeFrame: Month 1, 3, 6 post-operative
Secondary outcomes:
measure: amniotic membrane dislocation
timeFrame: DAY 1,7 post operative
measure: BCVA change
timeFrame: Time Frame: Preoperative,Month 1, 3, 6 post operative
measure: Retinal capillary plexus density change
timeFrame: Preoperative,Month 1, 3, 6 post operative
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Ophthalmology of Tianjin Medical University General Hospital
name: Hua Yan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: