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Active, not recruitingNCT05275972DETECT IIUpdated Nov 6, 2026

Descemet Endothelial Thickness Comparison Trial II

A Phase 3 interventional study of Ripasudil and Placebo in Fuchs, Fuchs Dystrophy and Fuchs' Endothelial Dystrophy, sponsored by Stanford University. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Stanford University · Phase 3, Interventional, and Treatment

Updated Nov 6, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

02

Conditions studied

  • Fuchs
  • Fuchs Dystrophy
  • Fuchs' Endothelial Dystrophy
03

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Browse Stanford University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
  • Peripheral endothelial cell count >1000 cells/mm2 in at least one quadrant
  • Good surgical candidate for either procedure as determined by the surgeon
  • Willingness to participate
  • Age greater than 18 years

Exclusion criteria

Exclusion Criteria:

  • Aphakia, anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK
  • Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
  • Other primary endothelial dysfunction such as PPMD
  • Visually significant optic nerve or macular pathology
  • Hypotony (Intraocular pressure \<10mmHg)
  • Any prior intraocular surgery other than cataract surgery
  • >3 clock hours of ANY anterior or posterior synechiae
  • >1 quadrant of stromal corneal vascularization
  • Inability to comply with post-operative instructions (i.e. unable to position)
  • Pregnancy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    DMEK plus topical placebo

    Drug: Placebo

  • Experimental
    DSO plus topical ripasudil 0.4%

    Drug: Ripasudil

Interventions

  • DrugRipasudil

    Topical Ripasudil 0.4%

  • DrugPlacebo

    Topical Placebo

06

What researchers measure

Primary outcomes

  1. Best spectacle-corrected visual acuity (BSCVA)

    Best spectacle-corrected visual acuity (BSCVA)

    Time frame: 12 months

Secondary outcomes

  1. Best spectacle-corrected visual acuity (BSCVA)

    Best spectacle-corrected visual acuity (BSCVA)

    Time frame: 3, 6 and 24 months

  2. Endothelial cell density

    Endothelial cell density

    Time frame: 3, 6, and 24 months

07

Study locations

8 sites
08

References and documents

Publications

  • Patel SV, Gupta N, Bhogal M, Jurkunas UV, Okumura N, Romano V, Allan BD, Baratz KH, Basak SK, Baydoun L, Chamberlain W, Chaurasia S, Colby K, Cursiefen C, Giobellina T, Greiner MA, Hjortdal J, Kobayashi A, Kocaba V, Koo EH, Lee WB, Livny E, Males JJ, Matthaei M, Mehta JS, Mejia L, Moloney G, Mootha VV, Muraine M, Oie Y, Pereira NC, Price FW Jr, Srikumaran D, Terry MA, Veldman PB, Verdier DD, Vaddavalli PK, Pineda R 2nd. Delphi-Based Global Consensus on Fuchs Endothelial Corneal Dystrophy. An Endothelial Keratoplasty Learners Group Initiative. Am J Ophthalmol. 2025 Dec;280:130-143. doi: 10.1016/j.ajo.2025.08.012. Epub 2025 Aug 9. PubMed 40789362 ↗
  • Lin CC, Chamberlain W, Benetz BA, Gensheimer W, Li JY, Jeng BH, Clover J, Varnado N, Abdelrahman S, Srinivasan A, Syed ZA, Koo EH, Arnold BF, Lietman TM, Lass J, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) with adjunctive ripasudil for Fuchs dystrophy. BMJ Open Ophthalmol. 2024 Oct 1;9(1):e001725. doi: 10.1136/bmjophth-2024-001725. PubMed 39353677 ↗
09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05275972
Lead sponsor
Stanford University
Collaborators
Oregon Health and Science University, University of California, San Francisco, University of California, Davis, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, University of Pennsylvania, University of Miami, Wills Eye Hospital, Devers Eye Institute
Responsible party
Jennifer Rose-Nussbaumer (Professor, Stanford University) — Principal investigator
First posted
Mar 11, 2022
Start date
Jan 23, 2023
Primary completion
Oct 30, 2027 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Jennifer Rose-Nussbaumer, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: K-115

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