NCT04344522

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 11, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

April 3, 2020

Last Update Submit

August 10, 2020

Conditions

Pseudophakic Bullous KeratopathyAnterior Chamber Intraocular Lens

Keywords

Descemet membrane endothelial keratoplasty DMEKAnterior chamber intraocular lens AC IOLpseudophakic bullous keratopathy PBK

Outcome Measures

Primary Outcomes (5)

  • 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

  • Best spectacle corrected visual acuity

    best spectacle corrected visual acuity using the decimal system

    3 months

  • 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 : 1. Microscopic hyphema : circulating red blood cells in the AC 2. Grade I : less than one third the AC 3. Grade II: one third to one half the AC 4. Grade III: more than one half the AC but not total 5. Grade IV : total hyphema. and intraocular pressure spikes will detected using the Goldmann applanation tonometer to measure the intraocular pressure in mmHg

    1month postoperatively

  • 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

  • Postoperative intraocular pressure spikes

    postoperative intracular pressure will be measured by Goldmann Applanation Tonometer in mmHg

    1 month postoperatively

Secondary Outcomes (4)

  • Keratometric values

    3 months

  • central corneal thickness

    3 months postoperatively

  • graft detachment

    1 week postoperatively

  • Spherical equivalent

    3 months postoperatively

Study Arms (2)

sequential 2 stage procedure

EXPERIMENTAL

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

Procedure: Descemet membrane endothelial keratoplasty DMEKProcedure: IOL exchangeProcedure: iridoplastyProcedure: Inferior peripheral iridectomy

combined single stage procedure

EXPERIMENTAL

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

Procedure: Descemet membrane endothelial keratoplasty DMEKProcedure: IOL exchangeProcedure: iridoplastyProcedure: Inferior peripheral iridectomy

Interventions

Descemet membrane endothelial keratoplasty DMEKPROCEDURE

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.

combined single stage proceduresequential 2 stage procedure
IOL exchangePROCEDURE

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.

combined single stage proceduresequential 2 stage procedure
iridoplastyPROCEDURE

iridoplasty : repairing any iris defect by using 10/0 prolene.

combined single stage proceduresequential 2 stage procedure
Inferior peripheral iridectomyPROCEDURE

Inferior peripheral iridectomy : performed by vannus scissor to avoid postoperative pupillary block due to the intracameral air .

combined single stage proceduresequential 2 stage procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, 21111, Egypt

RECRUITING

Related Publications (8)

  • 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.

    PMID: 18061137BACKGROUND

  • 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.

    PMID: 19182768BACKGROUND

  • 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.

    PMID: 19417653BACKGROUND

  • 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.

    PMID: 31228467BACKGROUND

  • 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.

    PMID: 29450379BACKGROUND

  • 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.

    PMID: 14604711BACKGROUND

  • 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.

    PMID: 24286840BACKGROUND

  • 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.

    PMID: 20970110BACKGROUND

Study Officials

  • Mohamed M Kolaib, MBBCh

    Alexandria Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Mohamed B Goweida, MD

    Alexandria Faculty of Medicine

    STUDY CHAIR

Central Study Contacts

Mohamed M Kolaib, MBBCh

CONTACT

00201283674800mohamedkolaib@hotmail.com

Mohamed B Goweida, MD

CONTACT

00201011755557mbahgat@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology resident

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 14, 2020

Study Start

August 11, 2020

Primary Completion

July 1, 2021

Study Completion

November 1, 2021

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)