Pseudophakic Bullous Keratopathy Clinical Trial
Official title:
Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery
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
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04191629 -
Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema
|
Phase 1 | |
| Recruiting |
NCT04387331 -
The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
|
||
| Not yet recruiting |
NCT05716945 -
The OPTIMISE Study
|
Phase 4 | |
| Completed |
NCT05531760 -
Predictive Factors of Graft Detachment Following Dmek
|
||
| Recruiting |
NCT04258787 -
OCT in Fuchs' Dystrophy
|
||
| Active, not recruiting |
NCT04894110 -
Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema
|
Phase 1 | |
| Completed |
NCT04420429 -
The Effect Of Preoperative Parameters On Success After DMEK Surgery
|
||
| Recruiting |
NCT05636579 -
Study to Assess Safety and Tolerability of Multiple Doses of EO2002
|
Phase 1 | |
| Completed |
NCT04520321 -
A Phase 1/ Phase 2 Study of TTHX1114(NM141)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05436665 -
The Belgian Endothelial Surgical Transplant of the Cornea
|
N/A | |
| Not yet recruiting |
NCT00623584 -
Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media
|
N/A |