Ignite Creation Date:
2024-05-06 @ 2:31 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04344522
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-04-03
Brief Title:
Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange Sequential Versus Combined Surgery
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange Sequential Versus Combined Surgery
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Surgical treatment of corneal endothelial decompensation in the presence of an anterior chamber intraocular lens AC IOL is technically challenging The ultimate management is to perform Descemet membrane endothelial keratoplasty DMEK However unfolding the DMEK graft in the presence of an AC IOL can be difficult and injurious to the graft so the investigators recommend exchanging the AC IOL with a posterior chamber IOL first In this study the investigators aim to compare the outcome and complications of performing DMEK and IOL exchange as combined one stage surgery versus sequential 2 stage procedure
Detailed Description:
Pseudophakic Bullous keratopathy is the second leading indication for endothelial keratoplasty One of the main controversies in the management of PBK in the presence of an AC IOl is whether to retain the IOL or perform an IOL exchange with a PC IOL The investigators believe that retention of an AC IOL can be hazardous to the DMEK graft due to reduced depth of the anterior chamber and traumatic touch between the graft and the IOL during graft unfolding and even postoperatively On the other hand performing an IOL exchange is relatively time consuming and requires excess manipulation of the iris tissue with the risk of intraoperative hyphema and postoperative inflammation which can affect the endothelial graft survival and cell count
Aim of the study to compare the outcome and complications between performing intraocular lens IOL exchange and Descemet membrane endothelial keratoplasty DMEK as single stage versus two stage procedure in the management of pseudophakic bullous keratopathy associated with anterior chamber IOL
Methods
The study will be a prospective randomized controlled trial Eligible subjects with pseudophakic bullous keratopathy and AC IOL will be assigned into two groups each comprising 10 eyes One group will undergo AC IOL exchange with posterior chamber PC IOL Poly methyl methacrylate PMMA lens or iris claw lens if there is no adequate capsular support combined with DMEK in the same setting The other group will undergo 2 stage procedure first one is IOL exchange iridoplasty if required and inferior peripheral iridectomy and the second stage is DMEK one month later
Aim of the study to compare the outcome and complications between performing intraocular lens IOL exchange and Descemet membrane endothelial keratoplasty DMEK as single stage versus two stage procedure in the management of pseudophakic bullous keratopathy associated with anterior chamber IOL
Methods
The study will be a prospective randomized controlled trial Eligible subjects with pseudophakic bullous keratopathy and AC IOL will be assigned into two groups each comprising 10 eyes One group will undergo AC IOL exchange with posterior chamber PC IOL Poly methyl methacrylate PMMA lens or iris claw lens if there is no adequate capsular support combined with DMEK in the same setting The other group will undergo 2 stage procedure first one is IOL exchange iridoplasty if required and inferior peripheral iridectomy and the second stage is DMEK one month later
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?:
True
Is an FDA AA801 Violation?:
None