DALK Corneal TransplantNCT03732599
Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK)
A study testing Standard Deep Anterior Keratoplasty (S-DALK) and IE-DALK (femtosecond) in people with DALK Corneal Transplant and Keratoconus, run by University of Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- DALK Corneal Transplant, Keratoconus, Scar
- What is being tested?
- Standard Deep Anterior Keratoplasty (S-DALK) and IE-DALK (femtosecond)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2015to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Either advanced keratoconus or corneal scarring requiring a deep anterior lamellar keratoplasty
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- DALK Corneal Transplant, Keratoconus, Scar
- Being tested
- Standard Deep Anterior Keratoplasty (S-DALK), IE-DALK (femtosecond)
- Medical subject headings
- Keratoconus, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Deep Anterior Keratoplasty (S-DALK)Procedure or surgery
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)Procedure or surgery
Femtosecond deep anterior lamellar keratoplasty (DALK). The femotosecond laser technology allows for the creation of precise and reproducible corneal incisions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: IE-DALK (femtosecond) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperatively, 6, 12 and 15 months postoperatively
Secondary outcomes (7)
Change from preoperative best-corrected distance visual acuity (BCVA)
BCVA will be measured using an ETDRS acuity chart and recorded in logMAR (logarithm of the minimal angle of resolution) units. Value range is between -0.125 and 3 logMAR. Lower values represent a better outcome.
Measured: preoperatively, 6, 12 and 15 months postoperatively.
Change from preoperative uncorrected distance visual acuity (UCVA)
UCVA will be measured using an ETDRS acuity chart and recorded in logMAR (logarithm of the minimal angle of resolution) units. Value range is between -0.125 and 3 logMAR. Lower values represent a better outcome.
Measured: preoperatively, 6, 12 and 15 months postoperatively.
Big-bubble success rate
This outcome represents the number of procedures where the deep anterior lamellar keratoplasty (DALK) procedure was completed using the "big bubble" surgical technique. This can either be "Yes" for successful or "No" for unsuccessful completion of this technique. Higher big-bubble success rates represent a better outcome.
Measured: 6 months postoperatively.
Rate of conversion to penetrating keratoplasty
This outcome represents the number of failed DALK procedures (using any of the possible DALK techniques) that needed to be converted to a procedure other than DALK (a penetrating keratoplasty procedure). This can either be "Yes" for DALK failure and conversion to penetrating keratoplasty or "No" for a successful DALK procedure. Higher penetrating keratoplasty conversion rates represent a worse outcome.
Measured: 6 months postoperatively.
Change from preoperative endothelial cell count
This is the density of corneal endothelial cells (measured as cells per square millimeter). Value range is between 300 and 3500 cells/square millimeter. Higher values represent a better outcome.
Measured: preoperatively, 6, 12 and 15 months postoperatively.
Change from preoperative pachymetry
This represents corneal thickness, measured in microns. Value ranges are between 200 and 800 microns. Values between 500 and 600 micron represents a good outcome.
Measured: preoperatively, 6, 12 and 15 months postoperatively.
Change from preoperative higher-order optical aberrations
Values of total higher-order optical aberrations and coma higher-order optical aberration measured in RMS (root mean square) units. Value range is between -20 and +20 RMS. Lower absolute value represents a better outcome (values closer to zero on both the negative and positive ends).
Measured: preoperatively, 6, 12 and 15 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start8 Apr 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DALK Corneal TransplantStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kensington Eye Institute, University Health Network, Toronto, Unity Health Toronto, Sunnybrook Health Sciences Centre, Applied Health Research Centre
- Responsible party
- Principal investigator, Neera Singal, Kensington Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732599
- Sponsor's protocol ID
- 30457
- Status last verified
- Nov 2018
- First submitted
- 10 Jul 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK)
- ClinicalTrials.gov ID
- NCT03732599
- Acronym / sponsor ID
- 30457
- Conditions
- DALK Corneal Transplant, Keratoconus, Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Kensington Eye Institute, University Health Network, Toronto, Unity Health Toronto, Sunnybrook Health Sciences Centre, Applied Health Research Centre
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard DALK | Active comparator | 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. |
| IE-DALK (femtosecond) | Active comparator | Procedure: IE-DALK (femtosecond)Femtosecond deep anterior lamellar keratoplasty (DALK). The femotosecond laser technology allows for the creation of precise and reproducible corneal incisions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 70 years
- Either advanced keratoconus or corneal scarring requiring a deep anterior lamellar keratoplasty
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Standard DALK |
| IE-DALK (femtosecond)Femtosecond deep anterior lamellar keratoplasty (DALK). The femotosecond laser technology allows for the creation of precise and reproducible corneal incisions. | Procedure or surgery | IE-DALK (femtosecond) |
Primary outcome
Change from preoperative topographical corneal astigmatism
Time frame: preoperatively, 6, 12 and 15 months postoperatively
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.
7 secondary outcomes
Change from preoperative best-corrected distance visual acuity (BCVA)
Time frame: preoperatively, 6, 12 and 15 months postoperatively.
Change from preoperative uncorrected distance visual acuity (UCVA)
Time frame: preoperatively, 6, 12 and 15 months postoperatively.
Big-bubble success rate
Time frame: 6 months postoperatively.
Rate of conversion to penetrating keratoplasty
Time frame: 6 months postoperatively.
Change from preoperative endothelial cell count
Time frame: preoperatively, 6, 12 and 15 months postoperatively.
Change from preoperative pachymetry
Time frame: preoperatively, 6, 12 and 15 months postoperatively.
Change from preoperative higher-order optical aberrations
Time frame: preoperatively, 6, 12 and 15 months postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
Related trials for DALK Corneal Transplant
RecruitingObservational study
The German Keratoplasty Registry of the German Ophthalmological Society (DOG)
Corneal Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Deep Anterior Keratoplasty (S-DALK) and IE-DALK (femtosecond) in people with DALK Corneal Transplant and Keratoconus, run by University of Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from preoperative topographical corneal astigmatism (time frame: preoperatively, 6, 12 and 15 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.