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

NCT03732599 | Unknown

• 1 other identifier: 30457
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from preoperative topographical corneal astigmatism

  Corneal astigmatism is the difference (expressed in Diopter units) of refractive power between the steep and flat corneal meridians and is measured using corneal topography. Values range between 0 and 20 diopters. Lower values represent a better outcome.

  preoperatively, 6, 12 and 15 months postoperatively

Secondary Outcomes (7)

• Change from preoperative best-corrected distance visual acuity (BCVA)

  preoperatively, 6, 12 and 15 months postoperatively.

• Change from preoperative uncorrected distance visual acuity (UCVA)

  preoperatively, 6, 12 and 15 months postoperatively.

• Big-bubble success rate

  6 months postoperatively.

• Rate of conversion to penetrating keratoplasty

  6 months postoperatively.

• Change from preoperative endothelial cell count

  preoperatively, 6, 12 and 15 months postoperatively.

Study Arms (2)

Standard DALK

ACTIVE COMPARATOR

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: Standard Deep Anterior Keratoplasty (S-DALK)

IE-DALK (femtosecond)

ACTIVE COMPARATOR

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

Procedure: IE-DALK (femtosecond)

Interventions

Standard Deep Anterior Keratoplasty (S-DALK) PROCEDURE

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.

Standard DALK

IE-DALK (femtosecond) PROCEDURE

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

IE-DALK (femtosecond)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years
• Either advanced keratoconus or corneal scarring requiring a deep anterior lamellar keratoplasty

You may not qualify if:

• Previous keratoplasty
• Advanced glaucoma
• Any other retinal or optic nerve pathology that could potentially affect visual outcome
• Strabismus or amblyopia
• Significant limbal stem cell deficiency (invlolving \> 3 limbal clock hours)
• Active autoimmune disease.

Sponsors & Collaborators

• University of Toronto: lead
• Kensington Eye Institute: collaborator
• University Health Network, Toronto: collaborator
• Unity Health Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Applied Health Research Centre: collaborator

MeSH Terms

Conditions

Keratoconus; Cicatrix

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Technologists who do the vision testing on participants are "masked" as to which "arm" the participant was randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cornea and Refractive Surgery

Model Details: This is a randomize study, in which half of the participants will be receiving either the standard deep anterior lamellar keratoplasty (DALK) (with a blade) technique or the femtosecond laser technique that creates the initial incisions instead of a blade.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: November 6, 2018
• Study Start: April 8, 2015
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2021
• Last Updated: November 27, 2018

Record last verified: 2018-11