KeratoconusPhase 1NCT02625467
Treatment of Keratoconus With PALK Versus PK
A Phase 1 study testing Penetrating keratoplasty, Pachymetry and Excimer laser assisted lamellar keratoplasty and Treatment posterior to surgery in people with Keratoconus, run by Instituto de Oftalmología Fundación Conde de Valenciana.
Trial summary
The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Penetrating keratoplasty, Pachymetry and Excimer laser assisted lamellar keratoplasty and Treatment posterior to surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Nov 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of keratoconus grades III or IV in the Amsler Krumeich classification.
- Need of surgical procedure
- No endothelial scar
- Best corrected visual acuity <20/40
- Contact lens intolerance
- Imagenological map pachymetric acquisition over 90% at 9 mm corneal diameter
Who cannot join
- Contraindication for any of the techniques evaluated.
- Requiring additional surgical procedures.
- Diagnostic of other ectasia that were not primary keratoconus.
About this study
Official title: Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)
The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).
- Conditions
- Keratoconus
- Being tested
- Penetrating keratoplasty, Pachymetry and Excimer laser assisted lamellar keratoplasty, Treatment posterior to surgery
- Keywords
- Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penetrating keratoplastyProcedure or surgery
Conventional Penetrating keratoplasty technique
Pachymetry and Excimer laser assisted lamellar keratoplastyProcedure or surgery
Ablation profile focusing on topography and pachymetry with Schwind Amaris excimer laser
Treatment posterior to surgeryDrug
Fluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte)
| Study group | Role | What they receive |
|---|---|---|
| Penetrating keratoplasty | Experimental | Conventional penetrating keratoplasty technique Receives: Procedure: Penetrating keratoplasty; Drug: Treatment posterior to surgery |
| PALK | Experimental | Pachymetry and Excimer laser assisted lamellar keratoplasty Receives: Procedure: Pachymetry and Excimer laser assisted lamellar keratoplasty; Drug: Treatment posterior to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Uncorrected and corrected distance visual acuity
Measured: 6 months
Secondary outcomes (4)
Corneal measurements: pachymetry
Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns
Measured: 6 months
Corneal aberrometry: Coma, spherical aberration and trefoil
Evaluation of the corneal aberrations including coma, spherical aberration and trefoil, with a Scheimpflug-Placido device (Sirius)
Measured: 6 months
Corneal measurements: anterior and posterior elevation
Evaluation of the elevation (anterior and posterior), maps with a Scheimpflug-Placido device (Sirius). Measurement in diopters
Measured: 6 months
Corneal measurements: keratometries.
Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Graue Hernandez, MD, MsC, Study director, Instituto de Oftalmologia Conde de Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625467
- Sponsor's protocol ID
- PALK vs PK
- Status last verified
- Dec 2015
- First submitted
- 1 Dec 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)
- ClinicalTrials.gov ID
- NCT02625467
- Acronym / sponsor ID
- PALK vs PK
- Conditions
- Keratoconus
- Keywords
- Keratoconus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Dec 2015 (estimated)
- 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.
The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penetrating keratoplasty | Experimental | Procedure: Penetrating keratoplasty, Drug: Treatment posterior to surgeryConventional penetrating keratoplasty technique |
| PALK | Experimental | Procedure: Pachymetry and Excimer laser assisted lamellar keratoplasty, Drug: Treatment posterior to surgeryPachymetry and Excimer laser assisted lamellar keratoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of keratoconus grades III or IV in the Amsler Krumeich classification.
- Need of surgical procedure
- No endothelial scar
- Best corrected visual acuity <20/40
- Contact lens intolerance
Key exclusion criteria (3 listed)
- Contraindication for any of the techniques evaluated.
- Requiring additional surgical procedures.
- Diagnostic of other ectasia that were not primary keratoconus.
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 |
|---|---|---|
| Penetrating keratoplastyConventional Penetrating keratoplasty technique | Procedure or surgery | Penetrating keratoplasty |
| Pachymetry and Excimer laser assisted lamellar keratoplastyAblation profile focusing on topography and pachymetry with Schwind Amaris excimer laser | Procedure or surgery | PALK |
| Treatment posterior to surgeryFluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte) | Drug | PALK, Penetrating keratoplasty |
Primary outcome
Visual acuity
Time frame: 6 months
Uncorrected and corrected distance visual acuity
4 secondary outcomes
Corneal measurements: pachymetry
Time frame: 6 months
Corneal aberrometry: Coma, spherical aberration and trefoil
Time frame: 6 months
Corneal measurements: anterior and posterior elevation
Time frame: 6 months
Corneal measurements: keratometries.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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.
Enrique Graue Hernandez, MD, MsC study director
Instituto de Oftalmologia Conde de Valenciana
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Penetrating keratoplasty, Pachymetry and Excimer laser assisted lamellar keratoplasty and Treatment posterior to surgery in people with Keratoconus, run by Instituto de Oftalmología Fundación Conde de Valenciana.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 9 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual acuity (time frame: 6 months). 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 9 Dec 2015.