Using Hydrated Amniotic Membrane to Help Close Refractory Macular Holes

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

This study is testing if using a special amniotic membrane can help people with stubborn macular holes heal better after eye surgery and improve their vision.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team (Academic / other)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05396209 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Hydrated Amniotic Membrane in promoting the closure of refractory macular holes. Patients with idiopathic macular holes will undergo pars plana vitrectomy surgery, where they will be randomized to receive either an amniotic membrane plug or conventional internal limiting membrane peeling. The study will assess both anatomical and functional outcomes through various eye examinations, including visual acuity and optical coherence tomography, at multiple postoperative intervals. The goal is to determine if the amniotic membrane can enhance healing and improve visual outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with idiopathic macular holes larger than 800μm who have not achieved closure after previous surgery.

Not a fit: Patients with smaller macular holes, traumatic macular holes, or those with known allergies to amniotic membrane may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve closure rates and visual acuity for patients with refractory macular holes.

How similar studies have performed: While the use of amniotic membrane in ocular surgeries has shown promise, this specific application for refractory macular holes is relatively novel and has not been extensively tested.

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.

Where this trial is running

Tianjin, Tianjin

• Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Hua Yan, MD,PhD — Ophthalmology of Tianjin Medical University General Hospital
• Study coordinator: Qihua Wang, MD

Conditions Macular Holes