Fruste KeratoconusNCT01726283
Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia
An observational study of Fruste Keratoconus and Risk of Ectasia, run by Cxlusa at 8 sites in United States.
Trial summary
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fruste Keratoconus, Risk of Ectasia
- What is being tested?
- Corneal Cross-Linking and Riboflavin
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2011to Jul 2014
- Phase
- Observational
- 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
Study population: Primary Care Clinic
Who may be able to join
- 18 years of age or older
- Up to 4 potential risk factors for ectasia
- A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
- B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
- C. Age 18 to 25
- D. Planned Residual stromal bed between 250 and 300 microns
Show all 10Show fewer
- Ability to provide written informed consent
- Likely to complete all study visits
- Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye
- Patients with and without previous laser vision correction are eligible for participation.
Who cannot join
- Frank keratoconus, Pellucid, or Post-LASIK ectasia
- Less than 20/30 BSCVA in either eye
- Corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
- Active Herpes Corneal Disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cleveland Eye Clinic
Breckville, Ohio
TLC Laser Eye Center
Fairfax, Virginia, 22031
The Center for Excellence in Eye Care
Miami, Florida
Minnesota Eye Consultants
Minneapolis, Minnesota
TLC Laser Eye Center
Rockville, Maryland, 20852
Clear View Eye & Laser Medical Center
San Diego, California
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
Talamo Laser Eye Center
Waltham, Massachusetts
About this study
Official title: Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.
Read the detailed description
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. CXL is thought to augment the tectonic strength of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. All excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with FDA approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. This can result in ectasia even in patients without pre-existing risk factors.
- Conditions
- Fruste Keratoconus, Risk of Ectasia
- Being tested
- Corneal Cross-Linking, Riboflavin
- Keywords
- fruste keratoconus, ectasia
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Cross-LinkingDevice
Corneal cross-linking procedure conducted during vision correction surgery.
RiboflavinDrug
Riboflavin will be instilled prior to corneal cross linking.
| Study group | Role | What they receive |
|---|---|---|
| low risk subjects for developing post-operative ectasia | Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia Receives: Device: Corneal Cross-Linking; Drug: Riboflavin | |
| Subjects at Risk for Ectasia | Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia Receives: Device: Corneal Cross-Linking; Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Best-Corrected Visual Acuity
Measured: Month 9
Secondary outcomes (1)
Residual Refractive error at the 1, 3 and 6 month visits
Measured: Months 1, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fruste 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cxlusa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Trattler, MD, Study director, Center For Excellence In Eye CareRoy Rubinfeld, Study director, CXL-USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726283
- Sponsor's protocol ID
- CXL-RSR
- Status last verified
- Aug 2015
- First submitted
- 9 Nov 2012
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia
- ClinicalTrials.gov ID
- NCT01726283
- Acronym / sponsor ID
- CXL-RSR
- Conditions
- Fruste Keratoconus, Risk of Ectasia
- Keywords
- fruste keratoconus, ectasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- CxlusaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Nov 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 is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.
Detailed description
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. CXL is thought to augment the tectonic strength of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. All excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with FDA approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. This can result in ectasia even in patients without pre-existing risk factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low risk subjects for developing post-operative ectasia | – | Device: Corneal Cross-Linking, Drug: RiboflavinPatients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia |
| Subjects at Risk for Ectasia | – | Device: Corneal Cross-Linking, Drug: RiboflavinPatients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (10 listed)
- 18 years of age or older
- Up to 4 potential risk factors for ectasia
- A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
- B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
- C. Age 18 to 25
Key exclusion criteria (6 listed)
- Frank keratoconus, Pellucid, or Post-LASIK ectasia
- Less than 20/30 BSCVA in either eye
- Corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
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 |
|---|---|---|
| Corneal Cross-LinkingCorneal cross-linking procedure conducted during vision correction surgery. | Device | Subjects at Risk for Ectasia, low risk subjects for developing post-operative ectasia |
| RiboflavinRiboflavin will be instilled prior to corneal cross linking. | Drug | Subjects at Risk for Ectasia, low risk subjects for developing post-operative ectasia |
Primary outcome
Postoperative Best-Corrected Visual Acuity
Time frame: Month 9
1 secondary outcome
Residual Refractive error at the 1, 3 and 6 month visits
Time frame: Months 1, 3, and 6
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 24 Aug 2015.
Related trials for Fruste Keratoconus
RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
RecruitingPhase 3
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
Down Syndrome (DS), Keratoconus
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.
William Trattler, MD study director
Center For Excellence In Eye Care
Roy Rubinfeld study director
CXL-USA
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fruste Keratoconus and Risk of Ectasia, run by Cxlusa at 8 sites 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 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: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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?
Postoperative Best-Corrected Visual Acuity (time frame: Month 9). 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 24 Aug 2015.