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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: Hydrated Amniotic Membrane Plug; Procedure: ILM filling; Procedure: Conventional ILM peeling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qihua Wang, MD; Phone Number: 86-10-18601180961; Email: wqha01696@btch.edu.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: Qihua Wang, MD; Phone Number: 86-10-18601180961; Email: wqha01696@btch.edu.cn
      • Contact: Hua Yan, MD, PhD; Phone Number: 86-22-60817010; Email: zyyyanhua@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydrated Amniotic Membrane Plug; Patients suffering from refractory macular holes as documented by spectral-domain OCT will undergo pars plan vitrectomy with Hydrated Amniotic Membrane insertion into the macular hole.	Procedure: Hydrated Amniotic Membrane Plug; Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole
Active Comparator: ILM filling; The ILM filling technique, in which free ILM is plug into the macular hole area	Procedure: 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
Active Comparator: Conventional ILM peeling; Peeling with complete removal of the internal limiting membrane within the vascular arch	Procedure: Conventional ILM peeling; Peeling with complete removal of the internal limiting membrane within the vascular arch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Anatomic closure	Rate of anatomic macular hole closure in the OCT at month 6	Month 6 post operative
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
BCVA change	change in the BCVA at Preoperative,1, 3, and 6 months	Time Frame: Preoperative,Month 1, 3, 6 post operative
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

Collaborators and Investigators

• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Investigators: Principal Investigator: Hua Yan, MD,PhD, Ophthalmology of Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): May 15, 2024
• Study Completion (Anticipated): June 15, 2025

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Dimenhydrinate
• Other Study ID Numbers: AMMH2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No