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

Primary Purpose

Pseudophakic Bullous Keratopathy, Anterior Chamber Intraocular Lens

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Descemet membrane endothelial keratoplasty DMEK
IOL exchange
iridoplasty
Inferior peripheral iridectomy
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudophakic Bullous Keratopathy focused on measuring Descemet membrane endothelial keratoplasty DMEK, Anterior chamber intraocular lens AC IOL, pseudophakic bullous keratopathy PBK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

sequential 2 stage procedure

combined single stage procedure

Arm Description

In this arm , the procedure will be performed in two stages ; the first stage will include performing IOL exchange together with iridoplasty ( if required) and inferior peripheral iridectomy (PI) and the second stage is performing DMEK one month later

In this arm, both IOL exchange and DMEK will be performed in the same setting

Outcomes

Primary Outcome Measures

postoperative endothelial cell loss in percentage
The postoperative endothelial cell count will be determined in cell/mm2 using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA) at 3 months and compared to the preoperative endothelial cell count of the donor graft to calculate the percentage of endothelial cell loss
Best spectacle corrected visual acuity
best spectacle corrected visual acuity using the decimal system
postoperative hyphema and and intraocular pressure spikes
Any postoperative hyphema and anterior chamber inflammatory reactions will determined by slit lamp examination: Hyphema if found will be graded into : Microscopic hyphema : circulating red blood cells in the AC Grade I : less than one third the AC Grade II: one third to one half the AC Grade III: more than one half the AC but not total Grade IV : total hyphema. and intraocular pressure spikes will detected using the Goldmann applanation tonometer to measure the intraocular pressure in mmHg
Postoperative AC inflammatory reactions
postoperative AC inflammatory reactions including cell and flare will be determined by slit lamp examination under high magnification: AC cells will be graded according to the Standardization of Uveitis Nomenclature (SUN) group grading system as following : Grade 0 : 5 or less cells in 1*1mm slit beam Grade 1 : 6- 15 cells in 1*1mm slit beam Grade II : 16-25 cells in 1*1mm slit beam Grade III : 26-50 cells in 1*1mm slit beam grade IV : more than 50 cells in 1*1mm slit beam . AC flare will be graded according to the SUN grading system : Grade 0 : none Grade I : faint Grade II : moderate ( iris and lens details still seen ) Grade III : Marked ( iris and lens details hazy) Grade IV : intense ( fixed and plastic aqueous ).
Postoperative intraocular pressure spikes
postoperative intracular pressure will be measured by Goldmann Applanation Tonometer in mmHg

Secondary Outcome Measures

Keratometric values
Keratometric values will be determined in Diopters using Autorefractometer/Keratometer , the difference between the steep and flat keratometric values will determine the corneal astigamtism in diopters
central corneal thickness
central corneal thickness will be determined in micrometer using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA)
graft detachment
The occurrence of postoperative graft detachment will be determined by slit lamp examination . The incidence of graft detachment will be determined in each group .
Spherical equivalent
spherical equivalent will be determined using the autorefractometer in diopters

Full Information

First Posted
April 3, 2020
Last Updated
August 10, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04344522
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakic Bullous Keratopathy, Anterior Chamber Intraocular Lens
Keywords
Descemet membrane endothelial keratoplasty DMEK, Anterior chamber intraocular lens AC IOL, pseudophakic bullous keratopathy PBK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sequential 2 stage procedure
Arm Type
Experimental
Arm Description
In this arm , the procedure will be performed in two stages ; the first stage will include performing IOL exchange together with iridoplasty ( if required) and inferior peripheral iridectomy (PI) and the second stage is performing DMEK one month later
Arm Title
combined single stage procedure
Arm Type
Experimental
Arm Description
In this arm, both IOL exchange and DMEK will be performed in the same setting
Intervention Type
Procedure
Intervention Name(s)
Descemet membrane endothelial keratoplasty DMEK
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IOL exchange
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
iridoplasty
Intervention Description
iridoplasty : repairing any iris defect by using 10/0 prolene.
Intervention Type
Procedure
Intervention Name(s)
Inferior peripheral iridectomy
Intervention Description
Inferior peripheral iridectomy : performed by vannus scissor to avoid postoperative pupillary block due to the intracameral air .
Primary Outcome Measure Information:
Title
postoperative endothelial cell loss in percentage
Description
The postoperative endothelial cell count will be determined in cell/mm2 using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA) at 3 months and compared to the preoperative endothelial cell count of the donor graft to calculate the percentage of endothelial cell loss
Time Frame
3 months
Title
Best spectacle corrected visual acuity
Description
best spectacle corrected visual acuity using the decimal system
Time Frame
3 months
Title
postoperative hyphema and and intraocular pressure spikes
Description
Any postoperative hyphema and anterior chamber inflammatory reactions will determined by slit lamp examination: Hyphema if found will be graded into : Microscopic hyphema : circulating red blood cells in the AC Grade I : less than one third the AC Grade II: one third to one half the AC Grade III: more than one half the AC but not total Grade IV : total hyphema. and intraocular pressure spikes will detected using the Goldmann applanation tonometer to measure the intraocular pressure in mmHg
Time Frame
1month postoperatively
Title
Postoperative AC inflammatory reactions
Description
postoperative AC inflammatory reactions including cell and flare will be determined by slit lamp examination under high magnification: AC cells will be graded according to the Standardization of Uveitis Nomenclature (SUN) group grading system as following : Grade 0 : 5 or less cells in 1*1mm slit beam Grade 1 : 6- 15 cells in 1*1mm slit beam Grade II : 16-25 cells in 1*1mm slit beam Grade III : 26-50 cells in 1*1mm slit beam grade IV : more than 50 cells in 1*1mm slit beam . AC flare will be graded according to the SUN grading system : Grade 0 : none Grade I : faint Grade II : moderate ( iris and lens details still seen ) Grade III : Marked ( iris and lens details hazy) Grade IV : intense ( fixed and plastic aqueous ).
Time Frame
1 month postoperatively
Title
Postoperative intraocular pressure spikes
Description
postoperative intracular pressure will be measured by Goldmann Applanation Tonometer in mmHg
Time Frame
1 month postoperatively
Secondary Outcome Measure Information:
Title
Keratometric values
Description
Keratometric values will be determined in Diopters using Autorefractometer/Keratometer , the difference between the steep and flat keratometric values will determine the corneal astigamtism in diopters
Time Frame
3 months
Title
central corneal thickness
Description
central corneal thickness will be determined in micrometer using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA)
Time Frame
3 months postoperatively
Title
graft detachment
Description
The occurrence of postoperative graft detachment will be determined by slit lamp examination . The incidence of graft detachment will be determined in each group .
Time Frame
1 week postoperatively
Title
Spherical equivalent
Description
spherical equivalent will be determined using the autorefractometer in diopters
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens. Age above 18 years old. Exclusion Criteria: Patients with corneal stromal scarring . Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M Kolaib, MBBCh
Phone
00201283674800
Email
mohamedkolaib@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed B Goweida, MD
Phone
00201011755557
Email
mbahgat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Kolaib, MBBCh
Organizational Affiliation
Alexandria Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed B Goweida, MD
Organizational Affiliation
Alexandria Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M Kolaib, MBBCh
Phone
00201283674800
Email
mohamedkolaib@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed B Goweida, MD
Phone
00201011755557
Email
mbahgat@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18061137
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.
Results Reference
background
PubMed Identifier
19182768
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.
Results Reference
background
PubMed Identifier
19417653
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.
Results Reference
background
PubMed Identifier
31228467
Citation
Woo JH, Ang M, Htoon HM, Tan D. Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty and Penetrating Keratoplasty. Am J Ophthalmol. 2019 Nov;207:288-303. doi: 10.1016/j.ajo.2019.06.012. Epub 2019 Jun 19.
Results Reference
background
PubMed Identifier
29450379
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.
Results Reference
background
PubMed Identifier
14604711
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.
Results Reference
background
PubMed Identifier
24286840
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.
Results Reference
background
PubMed Identifier
20970110
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.
Results Reference
background

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

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