NCT04344522

Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pseudophakic Bullous Keratopathy
• Anterior Chamber Intraocular Lens

Interventions

Type	Name	Description
PROCEDURE	Descemet membrane endothelial keratoplasty DMEK	DMEK : it involves separating the Descemet membrane from a corneal donor graft , doing a descematorhexis in the recepient cornea , loading and injection of the graft into the anterior chamber , unfolding and fixing the graft to the recepient cornea by intracameral air bubble.
PROCEDURE	IOL exchange	IOL exchange : it involves performing a corneoscleral tunnel , freeing the AC IOL from any adhesions and explanting it through the tunnel , then implanting a posterior chamber PMMA lens or iris claw lens if there is no adequate capsular support.
PROCEDURE	iridoplasty	iridoplasty : repairing any iris defect by using 10/0 prolene.
PROCEDURE	Inferior peripheral iridectomy	Inferior peripheral iridectomy : performed by vannus scissor to avoid postoperative pupillary block due to the intracameral air .

Timeline

• Start date: 2020-08-11
• Primary completion: 2021-07-01
• Completion: 2021-11-01
• First posted: 2020-04-14
• Last updated: 2020-08-12

Locations

1 site across 1 country: Egypt