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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-08

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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DALK Corneal Transplant Keratoconus Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Technologists who do the vision testing on participants are "masked" as to which "arm" the participant was randomized

Study Groups

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Standard 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.

Group Type ACTIVE_COMPARATOR

Standard Deep Anterior Keratoplasty (S-DALK)

Intervention Type 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.

IE-DALK (femtosecond)

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

Group Type ACTIVE_COMPARATOR

IE-DALK (femtosecond)

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

IE-DALK (femtosecond)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No