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Descemet Endothelial Thickness Comparison Trial (DETECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373137
Recruitment Status : Active, not recruiting
First Posted : February 26, 2015
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborators:
University of California, San Francisco
Stanford University
Information provided by (Responsible Party):
Winston Chamberlain, MD, PhD, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Keratoplasty Grafting, Corneal Transplantation, Corneal Transplantation, Cornea Keratoplasty, Lamellar Procedure: DSAEK Procedure: DMEK Device: Endoserter Drug: Prednisolone Drug: Ofloxacin Drug: Tropicamide Drug: Phenylephrine Device: Jones Tube Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Descemet Endothelial Thickness Comparison Trial
Actual Study Start Date : January 22, 2015
Actual Primary Completion Date : April 4, 2018
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
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:
  • Millipred
  • Orapred
  • Omnipred
  • Econopred
  • Flo-Pred

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 Name: Mydriacyl

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

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.
Procedure: DMEK
Drug: Prednisolone
Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Other Names:
  • Millipred
  • Orapred
  • Omnipred
  • Econopred
  • Flo-Pred

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 Name: Mydriacyl

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

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Endothelial Cell Count [ Time Frame: 3, 6, 12 months ]
  4. Endothelial Cell Count [ Time Frame: 24 months ]
  5. 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.

  6. Corneal Higher-Order Aberrations [ Time Frame: 24 months ]
    As measured by Pentacam

  7. Interface Haze [ Time Frame: 3, 6, 12 months ]
    As measured by Pentacam densitometry

  8. Interface Haze [ Time Frame: 24 months ]
    As measured by Pentacam densitometry

  9. 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.


  10. Graft Failure/Graft Rejection [ Time Frame: Baseline 12 months ]
  11. Graft Failure/Graft Rejection [ Time Frame: Baseline to 24 months ]

Other Outcome Measures:
  1. Refraction [ Time Frame: 3, 6, 12, 24 months ]
    Manifest refraction using phoropter

  2. Graft Thickness [ Time Frame: 3, 6, 12, 24 months ]
    As measured by Optical coherence tomography (OCT) and Pachymetry

  3. Operative Times [ Time Frame: Baseline ]
  4. Adverse Events/Complication Rates [ Time Frame: 3, 6, 12, 24 months ]
    composite measure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373137


Locations
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United States, California
Byers Eye Institute, Stanford University
Palo Alto, California, United States, 94303
F. I. Proctor Foundation, University of California, San Francisco
San Francisco, California, United States, 94143
United States, Oregon
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
University of California, San Francisco
Stanford University
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Winston Chamberlain, MD, PhD, Oregon Health and Science University:
Study Protocol  [PDF] October 2, 2017
Statistical Analysis Plan  [PDF] November 7, 2017

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Winston Chamberlain, MD, PhD, Ophthalmologist, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02373137    
Other Study ID Numbers: IRB00010818
First Posted: February 26, 2015    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Ofloxacin
Prednisolone
Phenylephrine
Oxymetazoline
Tropicamide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents
Cardiotonic Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents