KeratoconusPhase 3NCT01672814
Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus
A Phase 3 study testing riboflavin ophthalmic solution and Vedera KXS Microwave System in people with Keratoconus, run by Cornea and Laser Eye Institute at 1 site in United States.
Trial summary
This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure, also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in patients with keratoconus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- riboflavin ophthalmic solution and Vedera KXS Microwave System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 1 Jun 2017
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Provide written consent and sign a HIPAA form
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment and continue to use the method until 1 month after the last dose of investigational product.
- Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus
- Presence of central or inferior steepening on the Pentacam map
Show all 10Show fewer
- Steepest keratometry (Kmax) value greater than or equal to 51.00D
- BSCVA of 80 letters or fewer for keratoconus on ETDRS chart
- Contact lens wearers only: remove contact lenses one week prior to the screening refraction
- Contact lens wearers only: manifest refraction must be stable between two visits that occur at least 7 days apart.
Who cannot join
- Contraindications, sensitivity or known allergy to the use of the test articles(S) or their components
- If female, be pregnant, nursing, or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study
- Eyes classified as either normal,atypical normal,keratoconus suspect or mild keratoconus on the severity grading scheme
- A history of the insertion of INTACS in the eye to be treated
- A history of previous limbal relaxing incision procedure in the eye to be treated
- Corneal pachymetry that is <350 microns at the thinnest point measured by Pentacam in the eye to be treated
Show all 15Show fewer
- Eyes which are aphakic
- Eyes which are pseudophakic and do not have a UV blocking lens implanted
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
- A history of delayed epithelial healing in the eye to be treated
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
- Patients with a current condition that, in the investigator's opinion,would interfere with or prolong epithelial healing
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment
- A history of previous corneal cross-linking treatment in the eye to be treated
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea and Laser Eye Institue - Hersh Vision Group
Teaneck, New Jersey, 07666
About this study
Official title: A Randomized, Controlled Study of the Vedera™ KXS Microwave System With Corneal Collagen Cross-Linking Compared With Corneal Collagen Cross-Linking Alone for Eyes With Keratoconus
This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure, also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in patients with keratoconus.
Read the detailed description
The objective of this study is to compare the safety and efficacy of the Vedera KXS (a microwave-based procedure) combined with corneal collagen cross-linking performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL System to corneal collagen cross-linking alone in reducing corneal curvature in patients with keratoconus. Patients will be randomized into one of two treatment groups: Vedera KXS combined with corneal collagen cross-linking or collagen cross-linking alone. The Vedera KXS procedure performs a controlled application of microwave energy in an annular configuration. The goal of this procedure is to reshape the cornea to flatten the cornea and improve corneal topography in patients with keratoconus. The primary goal of collagen crosslinking is to stabilize the corneal shape in keratoconus and prevent progression of the disease. Moreover, investigations of crosslinking have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this study will compare the combined microwave/crosslinking treatment to crosslinking alone.
- Conditions
- Keratoconus
- Being tested
- riboflavin ophthalmic solution, Vedera KXS Microwave System
- Keywords
- Keratoconus, Collagen Crosslinking, Riboflavin, Microwave, Keraflex
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
riboflavin ophthalmic solutionDrug
Also called VibeX
Administration of riboflavin every 2 minutes for 20 minutes
Vedera KXS Microwave SystemDevice
Also called Keraflex
The Vedera KXS dose will be based on the pre-treatment manifest refraction spherical equivalent (MRSE), to be administered one day prior to the CXL procedure.
| Study group | Role | What they receive |
|---|---|---|
| Keraflex combined with Crosslinking | Active comparator | Vedera KXS microwave system used in conjunction with corneal collagen crosslinking performed with VibeX (Riboflavin ophthalmic solution)and the KXL UV System Receives: Drug: riboflavin ophthalmic solution; Device: Vedera KXS Microwave System |
| Corneal collagen crosslinking alone | Active comparator | Corneal collagen crosslinking alone performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL UV system Receives: Drug: riboflavin ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Keratometry
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint,the change in maximum keratometry (Kmax)from baseline will be evaluated at 1,3 and 6 months for all eyes.
Measured: 12 months
Secondary outcomes (1)
Manifest refraction
The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3,and 6 months to look at the effect of wound healing on this variable.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea and Laser Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter S Hersh, MD, Principal investigator, Cornea and Laser Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672814
- Sponsor's protocol ID
- VED-001
- Status last verified
- Jul 2018
- First submitted
- 22 Aug 2012
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of the Vedera™ KXS Microwave System With Corneal Collagen Cross-Linking Compared With Corneal Collagen Cross-Linking Alone for Eyes With Keratoconus
- ClinicalTrials.gov ID
- NCT01672814
- Acronym / sponsor ID
- VED-001
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Collagen Crosslinking, Riboflavin, Microwave, Keraflex
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cornea and Laser Eye InstituteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 27 Aug 2012 (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.
This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure, also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in patients with keratoconus.
Detailed description
The objective of this study is to compare the safety and efficacy of the Vedera KXS (a microwave-based procedure) combined with corneal collagen cross-linking performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL System to corneal collagen cross-linking alone in reducing corneal curvature in patients with keratoconus. Patients will be randomized into one of two treatment groups: Vedera KXS combined with corneal collagen cross-linking or collagen cross-linking alone. The Vedera KXS procedure performs a controlled application of microwave energy in an annular configuration. The goal of this procedure is to reshape the cornea to flatten the cornea and improve corneal topography in patients with keratoconus. The primary goal of collagen crosslinking is to stabilize the corneal shape in keratoconus and prevent progression of the disease. Moreover, investigations of crosslinking have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this study will compare the combined microwave/crosslinking treatment to crosslinking alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keraflex combined with Crosslinking | Active comparator | Drug: riboflavin ophthalmic solution, Device: Vedera KXS Microwave SystemVedera KXS microwave system used in conjunction with corneal collagen crosslinking performed with VibeX (Riboflavin ophthalmic solution)and the KXL UV System |
| Corneal collagen crosslinking alone | Active comparator | Drug: riboflavin ophthalmic solutionCorneal collagen crosslinking alone performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL UV system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be at least 18 years of age
- Provide written consent and sign a HIPAA form
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment and continue to use the method until 1 month after the last dose of investigational product.
- Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus
Key exclusion criteria (15 listed)
- Contraindications, sensitivity or known allergy to the use of the test articles(S) or their components
- If female, be pregnant, nursing, or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study
- Eyes classified as either normal,atypical normal,keratoconus suspect or mild keratoconus on the severity grading scheme
- A history of the insertion of INTACS in the eye to be treated
- A history of previous limbal relaxing incision procedure in the eye to be treated
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 |
|---|---|---|
| riboflavin ophthalmic solutionAlso: VibeXAdministration of riboflavin every 2 minutes for 20 minutes | Drug | Corneal collagen crosslinking alone, Keraflex combined with Crosslinking |
| Vedera KXS Microwave SystemAlso: KeraflexThe Vedera KXS dose will be based on the pre-treatment manifest refraction spherical equivalent (MRSE), to be administered one day prior to the CXL procedure. | Device | Keraflex combined with Crosslinking |
Primary outcome
Maximum Keratometry
Time frame: 12 months
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint,the change in maximum keratometry (Kmax)from baseline will be evaluated at 1,3 and 6 months for all eyes.
1 secondary outcome
Manifest refraction
Time frame: 12 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 17 Jul 2018.
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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.
Peter S Hersh, MD principal investigator
Cornea and Laser Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing riboflavin ophthalmic solution and Vedera KXS Microwave System in people with Keratoconus, run by Cornea and Laser Eye Institute at 1 site in United States.
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 10 inclusion and 15 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Maximum Keratometry (time frame: 12 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 17 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.