Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433284
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-22
Brief Title:
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
Sponsor:
Walailak University
Organization:
Walailak University
Study Overview
Official Title:
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes MACROHOLE a Randomized-control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MACROHOLE
Brief Summary:
The human amniotic membrane hAM patch introduced by Rizzo et al in 2018 showed a 100 anatomical success rate for large or failed macular holes over a 6-month follow-up Despite its regenerative properties like promoting angiogenesis and having low immunogenicity its clinical use is limited by challenges such as trimming to fit small holes and complications during insertion To overcome these issues decellularized amniotic membrane dAM has been processed into a hydrogel form enhancing its applicability and allowing it to be used as an injectable hydrogel for minimally invasive therapies While dAM hydrogels have been used in various medical fields their application in intraocular surgery is new This study proposes using dAM hydrogel for large macular hole closure comparing its effectiveness to the inverted ILM flap technique in a randomized controlled trial
Detailed Description:
A macular hole MH is a neuroepithelial defect in the macular area of the retina The estimation of macular hole incidence about 33 of every 10000 person in individuals older than 55 years old1 The female-to-male ratio is 2 to 31 Idiopathic macular hole IMH is MHs occurring independently of primary ocular diseases such as trauma and vitreoretinopathy2 and represents the predominant subtype of MH constituting approximately 831 There is a 5 to 15 risk of developing macular hole in the other eye if a macular hole develops in one eye1 In 1988 Gass proposed a classification system for idiopathic macular holes as well as a new hypothesis for its pathogenesis which emphasizes the role of the vitreo-macular tangential traction in the formation of macular holes3 Macular hole closure can occurred spontaneously in approximately 5-10 cases in early stages Pars plana vitrectomy with internal limiting membrane ILM peeling and gas tamponade has been the standard of care of small size macular hole treatment with success rate more than 904 However in large macular hole more than 400 um the success rate is lower Previous study showed closure rate of large macular hole 400 μm is 56 with poor visual outcome45 Several new techniques have been described to improve anatomical and functional outcomes in cases of large macular holes by inserting alternative tissues into the macular hole such as the ILM flap human amniotic membrane patch6 or retinal tissue implantation to promote anatomical closure and improve visual acuity The utilization of ILM flap coverage has emerged as an effective surgical approach for treating large full-thickness idiopathic MH and myopic MH This technique was initially introduced in 1999 showing promising results in enhancing macular hole closure rates through ILM peeling Several subsequent studies 7-9 have further substantiated the efficacy of ILM flap coverage making it the standard surgical treatment for large macular hole cases However this technique is often hindered by limitations related to the technical complexity of surgery and the risk of retinal trauma
The human amniotic membrane hAM patch proposed by Rizzo et al in 20186 serves as another alternative technique for large or failed macular hole cases The anatomical success rate was 100 during the 6 months follow-up The exceptional biological properties of hAM including its promote angiogenesis10 low immunogenicity11 and anti-inflammatory1112 anti-fibrotic13 and antibacterial characteristics14 make it highly suitable for regenerative medicine and intraocular implantation However the clinical application of thin hAM sheets is limited by several challenges such as the difficulty of trimming it to fit very small hole sizes 02 cm tissue loss after insertion into the PPV port and complications during the insertion of the hAM patch into the hole To address these limitations processing decellularized amniotic membrane dAM tissue into a hydrogel form has enhanced its processability and applicability15 This transformation allows it to be used as an injectable hydrogel for minimally invasive therapies and facilitates its manipulation into the macular hole
dAM hydrogels have been applied in various fields including skin repair cardiac treatment cartilage regeneration endometrial regeneration vascular grafts dental pulp regeneration and as cell culturecarrier platforms However their use in intraocular surgery has not yet been established Additionally the benefits of dAM hydrogel over hAM tissue include lower immunogenicity due to the decellularization processs since the resident cells may cause intense host immunologic reactions after transplantation and transplant rejection and the homogeneous distribution of biochemical substances within the hydrogel structure15 In this study we will be the first to propose a new technique and invention for closing large macular holes using human amniotic membrane hydrogel filling in the hole after standard ILM peeling We conducted a randomized controlled trial to compare the anatomical and visual outcomes of the inverted ILM flap technique IFT with the dHM hydrogel technique in idiopathic large macular holes with a minimum diameter MD greater than 400 μm
The human amniotic membrane hAM patch proposed by Rizzo et al in 20186 serves as another alternative technique for large or failed macular hole cases The anatomical success rate was 100 during the 6 months follow-up The exceptional biological properties of hAM including its promote angiogenesis10 low immunogenicity11 and anti-inflammatory1112 anti-fibrotic13 and antibacterial characteristics14 make it highly suitable for regenerative medicine and intraocular implantation However the clinical application of thin hAM sheets is limited by several challenges such as the difficulty of trimming it to fit very small hole sizes 02 cm tissue loss after insertion into the PPV port and complications during the insertion of the hAM patch into the hole To address these limitations processing decellularized amniotic membrane dAM tissue into a hydrogel form has enhanced its processability and applicability15 This transformation allows it to be used as an injectable hydrogel for minimally invasive therapies and facilitates its manipulation into the macular hole
dAM hydrogels have been applied in various fields including skin repair cardiac treatment cartilage regeneration endometrial regeneration vascular grafts dental pulp regeneration and as cell culturecarrier platforms However their use in intraocular surgery has not yet been established Additionally the benefits of dAM hydrogel over hAM tissue include lower immunogenicity due to the decellularization processs since the resident cells may cause intense host immunologic reactions after transplantation and transplant rejection and the homogeneous distribution of biochemical substances within the hydrogel structure15 In this study we will be the first to propose a new technique and invention for closing large macular holes using human amniotic membrane hydrogel filling in the hole after standard ILM peeling We conducted a randomized controlled trial to compare the anatomical and visual outcomes of the inverted ILM flap technique IFT with the dHM hydrogel technique in idiopathic large macular holes with a minimum diameter MD greater than 400 μm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None