KeratoconusPhase 3NCT01152541
Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin
A Phase 3 study testing Riboflavin/Dextran and Hypotonic Riboflavin in people with Keratoconus and Corneal Ectasia, run by Cornea and Laser Eye Institute at 1 site in United States.
Trial summary
Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus, Corneal Ectasia
- What is being tested?
- Riboflavin/Dextran and Hypotonic Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- A diagnosis of progressive keratoconus over a period of 24 months or less before randomization or a diagnosis of corneal ectasia after corneal refractive surgery
- Vision with contact lenses or glasses is worse than 20/20
- Corneal thickness greater than 300 microns at the thinnest point
Who cannot join
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
- Corneal pachymetry ≤ 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
- Clinically significant corneal scarring in the CXL treatment zone
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea and Laser Eye Institute
Teaneck, New Jersey, 07666
About this study
Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During the CXL procedure, the central corneal thickness has been shown to significantly change. The investigator's believe that better maintenance of corneal thickness potentially could have benefits of better reproducibility of the crosslinking effect with improved predictability of results.
Read the detailed description
The objective of this study is to investigate the difference between the two riboflavin preparations during UV (ultraviolet) administration. Both riboflavin preparations currently are in general use worldwide and in U.S. clinical trials of corneal collagen crosslinking. The first preparation contains riboflavin in a dextran solution, which may tend to dehydrate the cornea and keep it thinner. The second preparation contains riboflavin in a solution without dextran; in this case, the relative hypotonicity may tend to keep the cornea better hydrated and thicker. The primary goal of the study is to see if the use of hypotonic riboflavin (rather than riboflavin with dextran) better maintains consistent corneal thickness during the CXL procedure. The second goal of the study is to determine if better maintenance of corneal thickness potentially could have benefits of better consistency of the procedure, decrease in corneal haze formation, and improved safety of the endothelial cells. Safety and efficacy outcomes will then be compared between the groups. In particular, we will compare the corneal thickness measured by ultrasonic pachymetry immediately after the CXL procedure in the randomized eyes. Secondary outcomes will include visual acuity, longer term corneal thickness changes, and corneal steepness changes. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers
- Conditions
- Keratoconus, Corneal Ectasia
- Being tested
- Riboflavin/Dextran, Hypotonic Riboflavin
- Keywords
- Keratoconus, Corneal Ectasia, Collagen Crosslinking, Riboflavin
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin/DextranDrug
Also called Riboflavin in a dextran solution
Administration of riboflavin/dextran every 2 minutes for the duration of UV exposure
Hypotonic RiboflavinDrug
Also called Hypotonic (low salt) riboflavin solution without dextran
Administration of hypotonic riboflavin every 2 minutes for the duration of UV exposure.
| Study group | Role | What they receive |
|---|---|---|
| Hypotonic Riboflavin | Active comparator | Administration of hypotonic riboflavin every 2 minutes for the duration of UV exposure. Receives: Drug: Hypotonic Riboflavin |
| Riboflavin/dextran | Active comparator | Administration of Riboflavin/dextran every 2 minutes for the duration of UV exposure. Receives: Drug: Riboflavin/Dextran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal thickness
Changes in central pachymetry (as measured by ultrasound) measured intraoperatively will be compared to a baseline preoperative value. Thickness will also be assessed at 1, 3, 6 and 12 months postoperatively.
Measured: Intraoperatively
Secondary outcomes (4)
Maximum Keratometry
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to (Group 1 - administration of Riboflavin/dextran for the duration of UV exposure.) and (Group 2 - Administration of hypotonic riboflavin for the duration of UV exposure) groups. As a secondary analysis of this endpoint, the change in maximum keratometry (Kmax) from baseline will be evaluated at 1, 3 and 6 month for all eyes
Measured: 12 months
Manifest Refraction
The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As a 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 month for the treatment groups as well as at 3, and 6 months to look at the effect of CXL timing on this variable.
Measured: 12 months
Visual Acuity
Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint will be conducted to assess the profile of the treatments across time at 1 month and again at 3, and 6 months following the CXL procedure.
Measured: 12 months
Endothelial Cell Density
Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively. Measurements will also be taken 3 months postoperatively and compared to baseline values.
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 posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornea and Laser Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Hersh, MD, Principal investigator, Cornea and Laser Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152541
- Sponsor's protocol ID
- HYPO-CXL-001
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2010
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin
- ClinicalTrials.gov ID
- NCT01152541
- Acronym / sponsor ID
- HYPO-CXL-001
- Conditions
- Keratoconus, Corneal Ectasia
- Keywords
- Keratoconus, Corneal Ectasia, Collagen Crosslinking, Riboflavin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cornea and Laser Eye InstituteUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jun 2010 (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.
Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During the CXL procedure, the central corneal thickness has been shown to significantly change. The investigator's believe that better maintenance of corneal thickness potentially could have benefits of better reproducibility of the crosslinking effect with improved predictability of results.
Detailed description
The objective of this study is to investigate the difference between the two riboflavin preparations during UV (ultraviolet) administration. Both riboflavin preparations currently are in general use worldwide and in U.S. clinical trials of corneal collagen crosslinking. The first preparation contains riboflavin in a dextran solution, which may tend to dehydrate the cornea and keep it thinner. The second preparation contains riboflavin in a solution without dextran; in this case, the relative hypotonicity may tend to keep the cornea better hydrated and thicker. The primary goal of the study is to see if the use of hypotonic riboflavin (rather than riboflavin with dextran) better maintains consistent corneal thickness during the CXL procedure. The second goal of the study is to determine if better maintenance of corneal thickness potentially could have benefits of better consistency of the procedure, decrease in corneal haze formation, and improved safety of the endothelial cells. Safety and efficacy outcomes will then be compared between the groups. In particular, we will compare the corneal thickness measured by ultrasonic pachymetry immediately after the CXL procedure in the randomized eyes. Secondary outcomes will include visual acuity, longer term corneal thickness changes, and corneal steepness changes. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotonic Riboflavin | Active comparator | Drug: Hypotonic RiboflavinAdministration of hypotonic riboflavin every 2 minutes for the duration of UV exposure. |
| Riboflavin/dextran | Active comparator | Drug: Riboflavin/DextranAdministration of Riboflavin/dextran every 2 minutes for the duration of UV exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- A diagnosis of progressive keratoconus over a period of 24 months or less before randomization or a diagnosis of corneal ectasia after corneal refractive surgery
- Vision with contact lenses or glasses is worse than 20/20
- Corneal thickness greater than 300 microns at the thinnest point
Key exclusion criteria (8 listed)
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
- Corneal pachymetry ≤ 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
- Clinically significant corneal scarring in the CXL treatment zone
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
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/DextranAlso: Riboflavin in a dextran solutionAdministration of riboflavin/dextran every 2 minutes for the duration of UV exposure | Drug | Riboflavin/dextran |
| Hypotonic RiboflavinAlso: Hypotonic (low salt) riboflavin solution without dextranAdministration of hypotonic riboflavin every 2 minutes for the duration of UV exposure. | Drug | Hypotonic Riboflavin |
Primary outcome
Corneal thickness
Time frame: Intraoperatively
Changes in central pachymetry (as measured by ultrasound) measured intraoperatively will be compared to a baseline preoperative value. Thickness will also be assessed at 1, 3, 6 and 12 months postoperatively.
4 secondary outcomes
Maximum Keratometry
Time frame: 12 months
Manifest Refraction
Time frame: 12 months
Visual Acuity
Time frame: 12 months
Endothelial Cell Density
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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 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/Dextran and Hypotonic Riboflavin in people with Keratoconus and Corneal Ectasia, 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 4 inclusion and 8 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 8 Feb 2023. 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?
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?
Corneal thickness (time frame: Intraoperatively). 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 8 Feb 2023.