Clinical trial NCT04344522: Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery
Official title: Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pseudophakic Bullous Keratopathy
Anterior Chamber Intraocular Lens
Keywords: Descemet membrane endothelial keratoplasty DMEK
Anterior chamber intraocular lens AC IOL
pseudophakic bullous keratopathy PBK
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens.
2. Age above 18 years old.

Exclusion Criteria:

1. Patients with corneal stromal scarring .
2. Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.

Primary outcomes:
measure: postoperative endothelial cell loss in percentage
timeFrame: 3 months
measure: Best spectacle corrected visual acuity
timeFrame: 3 months
measure: postoperative hyphema and and intraocular pressure spikes
timeFrame: 1month postoperatively
measure: Postoperative AC inflammatory reactions
timeFrame: 1 month postoperatively
measure: Postoperative intraocular pressure spikes
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Keratometric values
timeFrame: 3 months
measure: central corneal thickness
timeFrame: 3 months postoperatively
measure: graft detachment
timeFrame: 1 week postoperatively
measure: Spherical equivalent
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Alexandria Faculty of Medicine
name: Mohamed M Kolaib, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria Faculty of Medicine
name: Mohamed B Goweida, MD
role: STUDY_CHAIR
References:
citation: Melles GR, Ong TS, Ververs B, van der Wees J. Preliminary clinical results of Descemet membrane endothelial keratoplasty. Am J Ophthalmol. 2008 Feb;145(2):222-227. doi: 10.1016/j.ajo.2007.09.021. Epub 2007 Dec 3.
citation: Ham L, Dapena I, van Luijk C, van der Wees J, Melles GR. Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye (Lond). 2009 Oct;23(10):1990-8. doi: 10.1038/eye.2008.393. Epub 2009 Jan 30.
citation: Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol. 2009 Jul;20(4):299-307. doi: 10.1097/ICU.0b013e32832b8d18.
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citation: Pricopie S, Istrate S, Voinea L, Leasu C, Paun V, Radu C. Pseudophakic bullous keratopathy. Rom J Ophthalmol. 2017 Apr-Jun;61(2):90-94. doi: 10.22336/rjo.2017.17.
citation: Ravalico G, Botteri E, Baccara F. Long-term endothelial changes after implantation of anterior chamber intraocular lenses in cataract surgery. J Cataract Refract Surg. 2003 Oct;29(10):1918-23. doi: 10.1016/s0886-3350(02)02052-7.
citation: Liarakos VS, Ham L, Dapena I, Tong CM, Quilendrino R, Yeh RY, Melles GR. Endothelial keratoplasty for bullous keratopathy in eyes with an anterior chamber intraocular lens. J Cataract Refract Surg. 2013 Dec;39(12):1835-45. doi: 10.1016/j.jcrs.2013.05.045.
citation: Gupta PK, Bordelon A, Vroman DT, Afshari NA, Kim T. Early outcomes of descemet stripping automated endothelial keratoplasty in pseudophakic eyes with anterior chamber intraocular lenses. Am J Ophthalmol. 2011 Jan;151(1):24-28.e1. doi: 10.1016/j.ajo.2010.07.003. Epub 2010 Oct 20.