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

NCT03732599 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-11-27

No results posted yet for this study

Summary

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.

Conditions

  • DALK Corneal Transplant
  • Keratoconus
  • Scar

Interventions

PROCEDURE

Standard Deep Anterior Keratoplasty (S-DALK)

Standard (with the use of a blade) deep anterior lamellar keratoplasty (DALK), which is a partial thickness corneal transplant, which has been shown to be a safe and effective procedure.

PROCEDURE

IE-DALK (femtosecond)

Femtosecond deep anterior lamellar keratoplasty (DALK). The femotosecond laser technology allows for the creation of precise and reproducible corneal incisions.

Sponsors & Collaborators

  • Kensington Eye Institute

    collaborator OTHER

  • University Health Network, Toronto

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Applied Health Research Centre

    collaborator OTHER

  • University of Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-08
Primary Completion
2019-12-31
Completion
2021-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732599 on ClinicalTrials.gov