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

NCT05396209 | Unknown

• 1 other identifier: AMMH2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• amniotic membrane dislocation

  DAY 1,7 post operative

• BCVA change

  Time Frame: Preoperative,Month 1, 3, 6 post operative

• Retinal capillary plexus density change

  Preoperative,Month 1, 3, 6 post operative

Study Arms (3)

Hydrated Amniotic Membrane Plug

ACTIVE COMPARATOR

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

ILM filling

ACTIVE COMPARATOR

The ILM filling technique, in which free ILM is plug into the macular hole area

Procedure: ILM filling

Conventional ILM peeling

ACTIVE COMPARATOR

Peeling with complete removal of the internal limiting membrane within the vascular arch

Procedure: Conventional ILM peeling

Interventions

Hydrated Amniotic Membrane Plug PROCEDURE

Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole

Hydrated Amniotic Membrane Plug

ILM filling PROCEDURE

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

ILM filling

Conventional ILM peeling PROCEDURE

Peeling with complete removal of the internal limiting membrane within the vascular arch

Conventional ILM peeling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• idiopathic macular hole diameter less than 800μm in minimum linear diameter;
• Macular hole caused by trauma and laser;
• Macular holes secondary to another vitreoretinal diseases;
• Macular hole of pathological myopia (axial length ≥26.0mm and diopter ≥6.00D，posterior scleral staphyloma，the atrophic choroid and retina with scleral exposure);
• Known to be allergic to amniotic membrane.
• Patients with any of the following eye diseases:
• Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc);
• Macular hole of other causes (secondary)；
• 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:
• Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)；
• Patients with ocular surgery.

Sponsors & Collaborators

• Oriental Neurosurgery Evidence-Based-Study Team: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Hua Yan, MD,PhD

  Ophthalmology of Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qihua Wang, MD

CONTACT

86-10-18601180961; wqha01696@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 31, 2022
• Study Start: June 1, 2022
• Primary Completion: May 15, 2024
• Study Completion: June 15, 2025
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

CN (1)