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Procedure

DSAEK for Corneal Grafting (DETECT Trial)

Phase 4

Waitlist Available

Led By Charles Lin, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12, 24 months

Awards & highlights

DETECT Trial Summary

This trial is comparing two types of eye surgery to see which one results in better vision afterward.

Eligible Conditions

Corneal Transplant
Corneal Grafting
Lamellar Keratoplasty

DETECT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Best Spectacle-Corrected Visual Acuity

Corneal Higher-Order Aberrations

Endothelial Cell Count

+3 more

Other outcome measures

Adverse Events/Complication Rates

Graft Thickness

Operative Times

+1 more

DETECT Trial Design

2Treatment groups

Experimental Treatment

Group I: DSAEKExperimental Treatment6 Interventions

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.

Group II: DMEKExperimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ofloxacin

FDA approved

Phenylephrine

FDA approved

DSAEK

2006

N/A

~80

DMEK

2016

N/A

~60

Tropicamide

FDA approved

Prednisolone acetate

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER

2,506 Previous Clinical Trials

15,238,517 Total Patients Enrolled

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,874 Total Patients Enrolled

Stanford UniversityOTHER

2,395 Previous Clinical Trials

17,341,317 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this trial?

"Currently, this research project is not accepting enrollees. This clinical trial was initially posted in January of 2015 and the last alteration to its entry occurred on November 19th 2020. If you are looking for other trials, there are currently 7 studies recruiting participants related to grafts and corneal treatments as well as 37 studies actively enrolling patients with regard to said treatment options."

Answered by AI

What other trials have been conducted to evaluate this therapeutic approach?

"This specific intervention was first examined in 2009 at Hospital de Clínicas de Porto Alegre. Since then, 266 studies have been successfully concluded and there are currently 37 active clinical trials spread out across San Francisco and Oregon."

Answered by AI

Has this treatment earned the seal of approval from the FDA?

"We have assigned a score of 3 to this treatment's safety, due to it having achieved Phase 4 status and thus being officially approved by relevant authorities."

Answered by AI

Are any more participants being sought for this experiment?

"According to clinicaltrials.gov, the trial has concluded its recruitment process and is no longer seeking participants. This investigation was originally posted on January 22nd 2015 with a most recent update occurring in November 2020. Fortunately though, there are 44 other trials actively recruiting at this time."

Answered by AI

To what ailments is this remedy regularly applied?

"This therapeutic intervention is typically prescribed to manage neoplastic maladies. However, there are other uses for it such as treating eye infections, bacterial ailments and partial cycloplegia."

Answered by AI

Recent research and studies

CorneaJournal

A Stepwise Approach to Donor Preparation and Insertion Increases Safety and Outcome of Descemet Membrane Endothelial Keratoplasty

Kruse, Friedrich E, Kathrin Laaser, Claus Cursiefen, Ludwig M Heindl, Ursula Schlötzer-Schrehardt, Stephan Riss, and Björn O Bachmann. 2011. “A Stepwise Approach to Donor Preparation and Insertion Increases Safety and Outcome of Descemet Membrane Endothelial Keratoplasty”. Cornea. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ico.0b013e3182000e2e.

OphthalmologyJournal

Ultrathin Descemet's Stripping Automated Endothelial Keratoplasty with the Microkeratome Double-pass Technique

Busin, Massimo, Silvana Madi, Paolo Santorum, Vincenzo Scorcia, and Jacqueline Beltz. 2013. “Ultrathin Descemet's Stripping Automated Endothelial Keratoplasty with the Microkeratome Double-pass Technique”. Ophthalmology. Elsevier BV. doi:10.1016/j.ophtha.2012.11.030.

CorneaJournal

Evolution of Endothelial Keratoplasty

Price, Francis W., and Marianne O. Price. 2013. “Evolution of Endothelial Keratoplasty”. Cornea. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ico.0b013e3182a0a307.

JAMA OphthalmologyJournal