Descemet Endothelial Thickness Comparison Trial

NCT02373137 | Unknown Phase 4 Results DMC

• 1 other identifier: IRB00010818
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to compare visual acuity outcomes of two types of endothelial keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2) Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be randomized to have DSAEK and the other half will have DMEK.

Conditions

Keratoplasty; Grafting, Corneal; Transplantation, Corneal; Transplantation, Cornea; Keratoplasty, Lamellar

Outcome Measures

Primary Outcomes (1)

• Best Spectacle-Corrected Visual Acuity

  The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).

  6 months

Secondary Outcomes (11)

• Best Spectacle-Corrected Visual Acuity

  3 and 12 months

• Best Spectacle-Corrected Visual Acuity

  24 Months

• Endothelial Cell Count

  3, 6, 12 months

• Endothelial Cell Count

  24 months

• Corneal Higher-Order Aberrations

  3, 6, 12 months

Other Outcomes (4)

• Refraction

  3, 6, 12, 24 months

• Graft Thickness

  3, 6, 12, 24 months

• Operative Times

  Baseline

Study Arms (2)

DSAEK

OTHER

Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.

Procedure: DSAEK; Device: Endoserter; Drug: Prednisolone; Drug: Ofloxacin; Drug: Tropicamide; Drug: Phenylephrine

DMEK

OTHER

Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.

Procedure: DMEK; Drug: Prednisolone; Drug: Ofloxacin; Drug: Tropicamide; Drug: Phenylephrine; Device: Jones Tube

Interventions

DSAEK PROCEDURE

DSAEK

DMEK PROCEDURE

DMEK

Endoserter DEVICE

The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.

DSAEK

Prednisolone DRUG

Prednisolone is a corticosteroid used to alleviate swelling post-surgery.

Also known as: Millipred, Orapred, Omnipred, Econopred, Flo-Pred

DMEK; DSAEK

Ofloxacin DRUG

Ofloxacin is an antibiotic used to treat bacterial infections of the eye.

Also known as: Ocuflox, Floxin

DMEK; DSAEK

Tropicamide DRUG

Tropicamide is a prescription drug used to dilate pupils during an eye exam.

Also known as: Mydriacyl

DMEK; DSAEK

Phenylephrine DRUG

Phenylephrine is a prescription drug used to dilate pupils during an eye exam.

DMEK; DSAEK

Jones Tube DEVICE

The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.

DMEK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Damaged or diseased endothelium from Fuchs or Pseudophakic Bullous Keratopathy
• Good candidates for corneal transplantation for either DMEK or DSAEK
• Willingness and ability to undergo a cornea transplantation
• Willingness to participate in follow-up visits

You may not qualify if:

• Participants who are decisionally and/or cognitively impaired
• Participants who are not suitable for the DMEK or DSAEK surgeries
• Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except uncomplicated cataract surgery
• Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal dystrophies and scars)
• Presence of a condition that increases the probability for failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
• Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
• Aphakia, or anterior chamber intraocular lens (IOL) in study eye prior to or anticipated during EK
• Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study at time of study EK
• Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
• Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
• Hypotony (Intraocular pressure \<10mmHg)
• Uncontrolled (defined as intraocular pressure \>25mmHg) glaucoma Visually significant optic nerve or macular pathology
• Visually significant optic nerve or macular pathology

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of California, San Francisco: collaborator
• Stanford University: collaborator

Study Sites (3)

Byers Eye Institute, Stanford University

Palo Alto, California, 94303, United States

Location

F. I. Proctor Foundation, University of California, San Francisco

San Francisco, California, 94143, United States

Location

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (10)

• Price FW Jr, Price MO. Evolution of endothelial keratoplasty. Cornea. 2013 Nov;32 Suppl 1:S28-32. doi: 10.1097/ICO.0b013e3182a0a307.

  PMID: 24104929 BACKGROUND

• Chen ES, Terry MA, Shamie N, Hoar KL, Friend DJ. Descemet-stripping automated endothelial keratoplasty: six-month results in a prospective study of 100 eyes. Cornea. 2008 Jun;27(5):514-20. doi: 10.1097/ICO.0b013e3181611c50.

  PMID: 18520497 BACKGROUND

• 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: 19182768 BACKGROUND

• Dirisamer M, van Dijk K, Dapena I, Ham L, Oganes O, Frank LE, Melles GR. Prevention and management of graft detachment in descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2012 Mar;130(3):280-91. doi: 10.1001/archophthalmol.2011.343. Epub 2011 Nov 14.

  PMID: 22084160 BACKGROUND

• Kruse FE, Laaser K, Cursiefen C, Heindl LM, Schlotzer-Schrehardt U, Riss S, Bachmann BO. A stepwise approach to donor preparation and insertion increases safety and outcome of Descemet membrane endothelial keratoplasty. Cornea. 2011 May;30(5):580-7. doi: 10.1097/ico.0b013e3182000e2e.

  PMID: 21598430 BACKGROUND

• Rudolph M, Laaser K, Bachmann BO, Cursiefen C, Epstein D, Kruse FE. Corneal higher-order aberrations after Descemet's membrane endothelial keratoplasty. Ophthalmology. 2012 Mar;119(3):528-35. doi: 10.1016/j.ophtha.2011.08.034. Epub 2011 Dec 22.

  PMID: 22197439 BACKGROUND

• Busin M, Madi S, Santorum P, Scorcia V, Beltz J. Ultrathin descemet's stripping automated endothelial keratoplasty with the microkeratome double-pass technique: two-year outcomes. Ophthalmology. 2013 Jun;120(6):1186-94. doi: 10.1016/j.ophtha.2012.11.030. Epub 2013 Mar 1.

  PMID: 23466268 BACKGROUND

• Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27.

  PMID: 21872938 BACKGROUND

• Ang MJ, Chamberlain W, Lin CC, Pickel J, Austin A, Rose-Nussbaumer J. Effect of Unilateral Endothelial Keratoplasty on Vision-Related Quality-of-Life Outcomes in the Descemet Endothelial Thickness Comparison Trial (DETECT): A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Jul 1;137(7):747-754. doi: 10.1001/jamaophthalmol.2019.0877.

  PMID: 31046075 DERIVED

• Chamberlain W, Lin CC, Austin A, Schubach N, Clover J, McLeod SD, Porco TC, Lietman TM, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty. Ophthalmology. 2019 Jan;126(1):19-26. doi: 10.1016/j.ophtha.2018.05.019. Epub 2018 Jun 23.

  PMID: 29945801 DERIVED

MeSH Terms

Conditions

Corneal Diseases

Interventions

Prednisolone; Methylprednisolone; Ofloxacin; Tropicamide; Phenylephrine

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. Jennifer Rose-Nussbaumer
• Organization: Kaiser Permanente / University of California, San Francisco

Jennifer.Rose-Nussbaumer@kp.org

650-299-2111

Study Officials

• Winston Chamberlain, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Jennifer Rose-Nussbaumer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Charles Lin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 26, 2015
• Study Start: January 22, 2015
• Primary Completion: April 4, 2018
• Study Completion: May 30, 2023
• Last Updated: November 25, 2020
• Results First Posted: July 2, 2019

Record last verified: 2020-11

Locations

US (3)