Descemet Endothelial Thickness Comparison Trial (DETECT)

November 19, 2020 updated by: Winston Chamberlain, MD, PhD, Oregon Health and Science University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Corneal transplantation has evolved rapidly in recent years. Lamellar keratoplasty to replace diseased endothelium has led to faster recovery times, fewer complications, and better visual acuity outcomes. Currently, Descemet's Stripping Endothelial Keratoplasty (DSAEK) is the most common procedure because of its relative ease and good outcomes. Newer techniques such as Descemet's Membrane Endothelial Keratoplasty (DMEK), where Descemet's membrane alone is transplanted, has the potential to further improve visual acuity outcomes, produce fewer higher-order corneal aberrations and decrease rejection rates. However, donor preparation, increased intra-operative times, and problems with donor attachment in DMEK are all important limitations.

There are three potential mechanisms by which DMEK may provide better visual acuity outcomes than DSAEK; graft thickness, interface haze and corneal higher-order aberrations. Graft thickness has been correlated with best spectacle corrected visual acuity (BSCVA) outcomes among thinner grafts. One retrospective case series found that 71% of thin endothelial grafts (defined as <131μm) had BSCVA of 20/25 or better while only 50% of thick grafts (defined as ≥131) achieved this. In addition, higher-order aberrations, in particular of the posterior cornea, are increased after DSAEK. Theoretically, given the decreased tissue transplanted after DMEK this would be lessened, however, one retrospective series looking at higher order aberrations in DMEK compared with DSAEK found no difference in posterior aberrations of the central 4.0 mm zone between the two groups. Finally, interface haze may be increased in DSAEK and has been correlated with BSCVA.

Ultrathin DSAEK involves donor preparation with a deep microkeratome pass to produce donor grafts less than 100 um thick. This procedure may have similar results to DMEK but without the technical difficulties. Several large prospective series show similar visual outcome results and rates of immunologic rejection between ultrathin DSAEK and DMEK, however comparisons are difficult. This comparative effectiveness clinical trial could directly address these important issues. The investigators also anticipate that secondary analyses of the trial data will allow us to address several more.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute, Stanford University
      • San Francisco, California, United States, 94143
        • F. I. Proctor Foundation, University of California, San Francisco
    • Oregon
      • Portland, Oregon, United States, 97239
        • Casey Eye Institute, Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DSAEK
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
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.
Drug: Prednisolone
Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Other Names:
  • Orapred
  • Flo-Pred
  • Millipred
  • Omnipred
  • Econopred
Drug: Ofloxacin
Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Other Names:
  • Ocuflox
  • Floxin
Drug: Tropicamide
Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Other Names:
  • Mydriacyl
Drug: Phenylephrine
Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
Other: DMEK
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.
Drug: Prednisolone
Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Other Names:
  • Orapred
  • Flo-Pred
  • Millipred
  • Omnipred
  • Econopred
Drug: Ofloxacin
Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Other Names:
  • Ocuflox
  • Floxin
Drug: Tropicamide
Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Other Names:
  • Mydriacyl
Drug: Phenylephrine
Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
Procedure: DMEK
Device: Jones Tube
The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Spectacle-Corrected Visual Acuity
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Spectacle-Corrected Visual Acuity
Time Frame: 3 and 12 months
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).
3 and 12 months
Best Spectacle-Corrected Visual Acuity
Time Frame: 24 Months
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).
24 Months
Endothelial Cell Count
Time Frame: 3, 6, 12 months
3, 6, 12 months
Endothelial Cell Count
Time Frame: 24 months
24 months
Corneal Higher-Order Aberrations
Time Frame: 3, 6, 12 months
Corneal anterior and posterior surface higher-order aberrations (HOA) were measured with Scheimpflug imaging (Pentacam) before surgery and at 3, 6, and 12 months post-operatively. Zernike orders 3-8 were calculated at 4.0- and 6.0-mm-diameter optical zones. The results reported here represent total HOA (Sum of Zernike orders 3-8). Note a single observation was not available for one eye in the DMEK group at 6 months, this was analyzed with last observation carried forward.
3, 6, 12 months
Corneal Higher-Order Aberrations
Time Frame: 24 months
As measured by Pentacam
24 months
Interface Haze
Time Frame: 3, 6, 12 months
As measured by Pentacam densitometry
3, 6, 12 months
Interface Haze
Time Frame: 24 months
As measured by Pentacam densitometry
24 months
National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ)
Time Frame: Baseline, 12 months

The National Eye Institute has developed the validated Visual Functioning Questionnaire (NEI-VFQ) to assess the effect of ocular conditions and vision on patient quality of life. The answers to the questionnaire are transformed into sub-scales, including: general health, general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision. Participants are assigned a numerical value for each sub-scale based on their answers between 0-100, where higher numbers indicate better visual function. These sub-scales are then combined according to National Eye Institute guidelines into an overall composite score for each participant. This overall composite score is also on a scale of 0-100, where higher numbers indicate better visual function.

Composite score based on National Eye Institute guidelines.
Baseline, 12 months
Graft Failure/Graft Rejection
Time Frame: Baseline 12 months
Baseline 12 months
Graft Failure/Graft Rejection
Time Frame: Baseline to 24 months
Baseline to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refraction
Time Frame: 3, 6, 12, 24 months
Manifest refraction using phoropter
3, 6, 12, 24 months
Graft Thickness
Time Frame: 3, 6, 12, 24 months
As measured by Optical coherence tomography (OCT) and Pachymetry
3, 6, 12, 24 months
Operative Times
Time Frame: Baseline
Baseline
Adverse Events/Complication Rates
Time Frame: 3, 6, 12, 24 months
composite measure
3, 6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

University of California, San Francisco
Stanford University

Investigators

  • Principal Investigator: Jennifer Rose-Nussbaumer, MD, University of California, San Francisco
  • Principal Investigator: Charles Lin, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2015

Primary Completion (Actual)

April 4, 2018

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00010818

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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