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

Macular Holes Clinical Trial

Official title:

Multicenter Case Control Clinical Trials to Compare the Healing Process of Refractory Macular Hole With Different Surgical Techniques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396209
• Other study ID #: AMMH2022
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 15, 2025

Study information

• Verified date: May 2022
• Source: Oriental Neurosurgery Evidence-Based-Study Team
• Contact: Qihua Wang, MD
• Phone: 86-10-18601180961
• Email: wqha01696[@]btch.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 15, 2025
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Hydrated Amniotic Membrane Plug
Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole
• ILM filling
The ILM filling technique - Rossi et al show that ILM filling technique was more efficacious in closing full-thickness macular holes larger than 630µm, in which the free ILM after peeling is plug into the area of the macular hole
• Conventional ILM peeling
Peeling with complete removal of the internal limiting membrane within the vascular arch

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Oriental Neurosurgery Evidence-Based-Study Team

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Anatomic closure	Rate of anatomic macular hole closure in the OCT at month 6	Month 6 post operative
Primary	Reconstruction of the foveal layered retinal structure change	Change in the reconstruction of the foveal layered retinal structure by OCT at 1, 3, and 6 months	Month 1, 3, 6 post-operative
Secondary	amniotic membrane dislocation	conform amniotic membrane dislocation in the OCT and/or binocular indirect ophthalmoscope at day 1 and 7	DAY 1,7 post operative
Secondary	BCVA change	change in the BCVA at Preoperative,1, 3, and 6 months	Time Frame: Preoperative,Month 1, 3, 6 post operative
Secondary	Retinal capillary plexus density change	change in the retinal capillary plexus density with OCT-A at Preoperative,1, 3, and 6 months	Preoperative,Month 1, 3, 6 post operative