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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04344522
Other study ID # DMEK ACIOL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2020
Est. completion date November 1, 2021

Study information

Verified date August 2020
Source Alexandria University
Contact Mohamed M Kolaib, MBBCh
Phone 00201283674800
Email mohamedkolaib@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
iridoplasty
iridoplasty : repairing any iris defect by using 10/0 prolene.
Inferior peripheral iridectomy
Inferior peripheral iridectomy : performed by vannus scissor to avoid postoperative pupillary block due to the intracameral air .

Locations

Country Name City State
Egypt Faculty of Medicine Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months
Primary Best spectacle corrected visual acuity best spectacle corrected visual acuity using the decimal system 3 months
Primary 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
1month postoperatively
Primary 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 ).
1 month postoperatively
Primary Postoperative intraocular pressure spikes postoperative intracular pressure will be measured by Goldmann Applanation Tonometer in mmHg 1 month postoperatively
Secondary 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 3 months
Secondary central corneal thickness central corneal thickness will be determined in micrometer using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA) 3 months postoperatively
Secondary 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 . 1 week postoperatively
Secondary Spherical equivalent spherical equivalent will be determined using the autorefractometer in diopters 3 months postoperatively
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