The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study

NCT04904679 | Active Not Recruiting

• 1 other identifier: HAMprotocol
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane (AM) or internal limiting membrane ( ILM ).

Conditions

Macular Holes

Keywords

Human Amniotic Membranes in macular holes using microperimetry

Outcome Measures

Primary Outcomes (2)

• The retinal sensitivity

  measured by the microperimetry

  through study completion, an average of 1 year

• The fixation stability

  measured by the microperimetry

  through study completion, an average of 1 year

Secondary Outcomes (1)

• the macula hole closure rate

  through study completion, an average of 1 year

Study Arms (2)

Amniotic Membrane group

ACTIVE COMPARATOR

Patients who will be treated with a amniotic membrane plug

Device: Pars plana Vitrectomy with internal limiting membrane peeling

Internal Limiting Membrane group

ACTIVE COMPARATOR

patients who will be treated with a internal limiting membrane flap

Device: Pars plana Vitrectomy with internal limiting membrane peeling

Interventions

Pars plana Vitrectomy with internal limiting membrane peeling DEVICE

The pars plana 23-gauge (23G) vitrectomy technique will be performed with removal of the internal limiting membrane (ILM) (when adhered to the macula) and placement of either an amniotic membrane plug or an ILM flap in the macular hole. This will be followed by a fluid-air exchange and buffering gas infusion (12.5% C3F8). The amniotic membrane plug will be prepared using a dermatological punch with a diameter of 1 to 2 mm, depending on the size of the macular hole as measured by OCT. It will be positioned inside the macular hole using 23G forceps, with its chorionic side facing the retinal pigmented epithelium (RPE). The ILM flap will be created at the time of peeling-with an inverted flap in primary cases and a free flap in refractory cases. It will be positioned over the hole (inverted flap) or inside the macular hole (free flap) using 23G ILM forceps. These techniques will be assisted by the use of an extra lighting sclerotomy.

Also known as: Use of Amniotic membrane plug, Use of a internal limiting membrane inverted flap, gas tamponade (C3F8 12,5%)

Amniotic Membrane group; Internal Limiting Membrane group

Eligibility Criteria

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

You may qualify if:

• Patients with a macula hole that falls into the two categories below:
• Patients with idiopathic macular hole (with no history of secondary macular hole) ≥ 600 microns (measured using optical coherence tomography)
• Patients with an idiopathic macular hole submitted to conventional treatment without closing it (of any size).
• History of the disease less than 18 months
• Aged over 18 years old
• Visual acuity less than 20/32

You may not qualify if:

• History of any previous macular disease other than idiopathic macular hole
• Macular hole of other causes (secondary)
• Patients with diabetic retinopathy or other retinal vascular diseases
• Eyes subjected to intravitreal injection of any medication
• Visual acuity \<20/400 of any retinal cause in the contralateral eye or absence of the globe \*Aged under 50 years old
• Cataract and anti-glaucoma surgery less than 3 months before the study
• Glaucoma with optic nerve excavation \> 0.7 in the studied eye
• Intraocular pressure \> 24 mmHg with the use of maximum medication in the studied eye
• History of vitreoretinal surgery for a condition other than the idiopathic macular hole (retinal detachment, vitreous hemorrhage)
• History of retinal detachment of any etiology
• A patient who manifests himself not being able to perform the head position in the postoperative period
• A patient with active anterior or posterior uveitis

Sponsors & Collaborators

• Hospital Oftalmologico de Sorocaba: lead

Study Sites (2)

Hospital Oftalmologico de Sorocaba/ Banco de Olhos de Sorocaba

Sorocaba, São Paulo, 18031060, Brazil

Location

Sorocaba Eye's Hospital

Sorocaba, São Paulo, 18031060, Brazil

Location

Related Publications (11)

• Jirsova K, Jones GLA. Amniotic membrane in ophthalmology: properties, preparation, storage and indications for grafting-a review. Cell Tissue Bank. 2017 Jun;18(2):193-204. doi: 10.1007/s10561-017-9618-5. Epub 2017 Mar 2.

  PMID: 28255771 RESULT

• Ferreira MA, Maia A, Machado AJ, Ferreira REA, Hagemann LF, Junior PHER, Rezende FA. Human amniotic membrane for the treatment of large and refractory macular holes: a retrospective, multicentric, interventional study. Int J Retina Vitreous. 2021 May 8;7(1):38. doi: 10.1186/s40942-021-00308-6.

  PMID: 33964971 RESULT

• Caporossi T, Tartaro R, De Angelis L, Pacini B, Rizzo S. A human amniotic membrane plug to repair retinal detachment associated with large macular tear. Acta Ophthalmol. 2019 Dec;97(8):821-823. doi: 10.1111/aos.14109. Epub 2019 Apr 6.

  PMID: 30953398 RESULT

• Rizzo S, Caporossi T, Tartaro R, Finocchio L, Franco F, Barca F, Giansanti F. A Human Amniotic Membrane Plug to Promote Retinal Breaks Repair and Recurrent Macular Hole Closure. Retina. 2019 Oct;39 Suppl 1:S95-S103. doi: 10.1097/IAE.0000000000002320. No abstract available.

  PMID: 30312261 RESULT

• Caporossi T, Pacini B, De Angelis L, Barca F, Peiretti E, Rizzo S. HUMAN AMNIOTIC MEMBRANE TO CLOSE RECURRENT, HIGH MYOPIC MACULAR HOLES IN PATHOLOGIC MYOPIA WITH AXIAL LENGTH OF >/=30 mm. Retina. 2020 Oct;40(10):1946-1954. doi: 10.1097/IAE.0000000000002699.

  PMID: 31868775 RESULT

• Meyer CH, Borny R, Horchi N. Subretinal fluid application to close a refractory full thickness macular hole. Int J Retina Vitreous. 2017 Nov 27;3:44. doi: 10.1186/s40942-017-0094-7. eCollection 2017.

  PMID: 29209516 RESULT

• Kase S, Saito W, Mori S, Saito M, Ando R, Dong Z, Suzuki T, Noda K, Ishida S. Clinical and histological evaluation of large macular hole surgery using the inverted internal limiting membrane flap technique. Clin Ophthalmol. 2016 Dec 16;11:9-14. doi: 10.2147/OPTH.S119762. eCollection 2017.

  PMID: 28031697 RESULT

• Ch'ng SW, Patton N, Ahmed M, Ivanova T, Baumann C, Charles S, Jalil A. The Manchester Large Macular Hole Study: Is it Time to Reclassify Large Macular Holes? Am J Ophthalmol. 2018 Nov;195:36-42. doi: 10.1016/j.ajo.2018.07.027. Epub 2018 Jul 30.

  PMID: 30071212 RESULT

• Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.

  PMID: 19846059 RESULT

• Lois N, Burr J, Norrie J, Vale L, Cook J, McDonald A, Boachie C, Ternent L, McPherson G; Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group. Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial. Invest Ophthalmol Vis Sci. 2011 Mar 1;52(3):1586-92. doi: 10.1167/iovs.10-6287.

  PMID: 21051731 RESULT

• Carvalho Araujo AC, Bordon AF, Falcao V, Bortolai P, Dib E, Maia M. The use of amniotic membrane or inverted internal limiting membrane flap for large or refractory macular holes: a prospective, comparative study using microperimetry. Graefes Arch Clin Exp Ophthalmol. 2025 Sep 15. doi: 10.1007/s00417-025-06917-3. Online ahead of print.

  PMID: 40952489 DERIVED

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist , MD

Model Details: Prospective, randomized, unmasked single center interventional study

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: June 26, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)