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NCT03732599

Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK)

Status unknown NA Last updated 27 November 2018
What this trial tests

NA trial testing Standard Deep Anterior Keratoplasty (S-DALK) in DALK Corneal Transplant in 100 participants. Status unknown.

Timeline
8 April 2015
Primary endpoint
31 December 2019
31 May 2021

Quick facts

Lead sponsorUniversity of Toronto
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment100
Start date8 April 2015
Primary completion31 December 2019
Estimated completion31 May 2021

Drugs / interventions tested

Conditions studied

Sponsor

University of Toronto

Who can join

Adults 18 to 70, any sex, with DALK Corneal Transplant or Keratoconus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A prospective comparison between standard deep anterior lamellar keratoplasty (S-DALK) performed manually using a blade (trephine) and femtosecond laser-enabled deep anterior lamellar keratoplasty (IE DALK), where incisions are performed using the femtosecond laser.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Deep anterior lamellar keratoplasty for keratoconus: Elements for success.
    Pellegrini M, Yu AC, Busin M. · · 2022 · cited 7× · PMID 35971490 · DOI 10.4103/sjopt.sjopt_100_21
  2. A randomized controlled trial comparing femtosecond-enabled deep anterior lamellar keratoplasty and standard deep anterior lamellar keratoplasty (FEDS Study).
    Sorkin N, Hatch W, Mimouni M, Chew HF, et al · · 2023 · cited 2× · PMID 36693916 · DOI 10.1038/s41433-023-02387-1

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Other University of Toronto trials

Trials by the same sponsor.

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