Clinical trial NCT03732599: Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK)
Official title: Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: DALK Corneal Transplant
Keratoconus
Scar
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Kensington Eye Institute
name: University Health Network, Toronto
name: Unity Health Toronto
name: Sunnybrook Health Sciences Centre
name: Applied Health Research Centre
First posted: 2018-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from preoperative topographical corneal astigmatism
timeFrame: preoperatively, 6, 12 and 15 months postoperatively
Secondary outcomes:
measure: Change from preoperative best-corrected distance visual acuity (BCVA)
timeFrame: preoperatively, 6, 12 and 15 months postoperatively.
measure: Change from preoperative uncorrected distance visual acuity (UCVA)
timeFrame: preoperatively, 6, 12 and 15 months postoperatively.
measure: Big-bubble success rate
timeFrame: 6 months postoperatively.
measure: Rate of conversion to penetrating keratoplasty
timeFrame: 6 months postoperatively.
measure: Change from preoperative endothelial cell count
timeFrame: preoperatively, 6, 12 and 15 months postoperatively.
measure: Change from preoperative pachymetry
timeFrame: preoperatively, 6, 12 and 15 months postoperatively.
measure: Change from preoperative higher-order optical aberrations
timeFrame: preoperatively, 6, 12 and 15 months postoperatively.
Other outcomes:
Locations:
Study officials:
References: