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

University of Toronto

Status: Unknown

Conditions: Keratoconus; DALK Corneal Transplant; Scar

Treatments: Procedure: Standard Deep Anterior Keratoplasty (S-DALK); Procedure: IE-DALK (femtosecond)

Study type: Interventional

Funder types: Other

Identifiers

NCT03732599

30457

Details and patient eligibility

About

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.

Full description

Even though corneal transplants have been around for more than 100 years, and tools to improve their surgical technique keep getting perfected, both regular and irregular postoperative astigmatism continue to be major concerns in achieving predictable visual results. Femtosecond laser technology allows for the creation of more precise incisions with more reproducible patterns, which could lead us to believe that astigmatism management and visual results should be improved with this technology. This would be the first study to prospectively analyze standard versus femtosecond laser-enabled deep anterior lamellar keratoplasties in order to elucidate their relative advantages in the quest for a gold standard.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Standard DALK

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Deep Anterior Keratoplasty (S-DALK)

IE-DALK (femtosecond)

Active Comparator group

Description:

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

Treatment:

Procedure: IE-DALK (femtosecond)