KeratoconusNCT01789333
Higher Irradiance in Keratoconus Ectasia
A study testing UVA Light with irradiance exposure of 9 mW/cm2 and Riboflavin 0.1% ophthalmic solution in people with Keratoconus and Ectasia, run by Stephen Trokel at 1 site in United States.
Trial summary
The purpose of the study is to see if brighter lights will allow for shortening of the treatment time required to stabilize the eyes of patients with keratoconus or a bulging cornea. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Keratoconus, Ectasia
- What is being tested?
- UVA Light with irradiance exposure of 9 mW/cm2 and Riboflavin 0.1% ophthalmic solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to 30 Dec 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:
- 16 years of age or older
- Having a diagnosis of progressive keratoconus or pellucid marginal degeneration.
- Characteristic pattern of deformity as analyzed by the Pentacam map.
- Minimal thickness of 350 microns
- The ability to sign a written informed consent
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- States a willingness and ability to comply with schedule for follow-up visits
- Subject willing to remove contact lenses prior to evaluation and treatment
- History of having undergone a keratorefractive procedure and show:
- Steepening by Pentacam study
- Thinning of cornea
- Shift in the position of thinnest portion of cornea
- Unstable refraction with increasing myopia and astigmatism
- Development of irregular astigmatism
- At least two of the above criteria must be present.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from this study:
- Subjects meeting any of the following criteria will be excluded from this protocol:
- Eyes classified as either normal or atypical normal,
- Corneal pachymetry ≤ 350 microns at the thinnest point in treatment zone measured by Pentacam.
- A history of delayed epithelial healing.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
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- A known sensitivity to study medications
- Patients with nystagmus or any other condition that is severe enough to prevent steady gaze during the treatment
- Inability to cooperate with diagnostic tests.
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Patients who are unable to remain supine and tolerate a lid speculum.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Harkness Eye Institute-Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross- Linking at Higher Irradiances in Patients With Keratoconus or Ectasia
The purpose of the study is to see if brighter lights will allow for shortening of the treatment time required to stabilize the eyes of patients with keratoconus or a bulging cornea. The investigators will be comparing the therapeutic effects of two different higher brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as bright as the other and the exposure time of these brighter lights to deliver equivalent energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes. Riboflavin is vitamin B2 and the investigators are trying to determine if an identical clinical effect can be achieved the brighter treatment lights are used for shorter times. The investigators will also monitor the clinical effect and the status of the cornea to see if additional risks are associated with the brighter light.
- Conditions
- Keratoconus, Ectasia
- Being tested
- UVA Light with irradiance exposure of 9 mW/cm2, Riboflavin 0.1% ophthalmic solution
- Keywords
- Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK, irregular astigmatism
- Medical subject headings
- Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVA Light with irradiance exposure of 9 mW/cm2Device
The device's light emitting diode (LED) is used to deliver a metered dose of Ultraviolet A (UVA) light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
The aperture setting will be set at 10 mm, and the eye will be irradiated for 10 minutes for the high irradiance exposure of 9 milliwatts (mW)/cm2. During the exposure, instillation of riboflavin will continue (1 drop every 3 minutes).
Riboflavin 0.1% ophthalmic solutionDrug
Also called Riboflavin
The speculum is removed and one (1) drop of Riboflavin 0.1% ophthalmic solution will be instilled topically in the eye every 3 minutes for 30 minutes. At the end of the 30 minute riboflavin pre-treatment period, the eye will be examined to assure the presence of a yellow flare in the anterior chamber, indicating riboflavin saturation of the corneal tissue. If the yellow flare is not detected, riboflavin will continue to be instilled until the presence of the yellow flare in the anterior chamber is confirmed.
During UVA irradiation, instillation of riboflavin will be continued every 3 minutes. For a 30-minute pre-treatment and 30-minute irradiation, the total dose of riboflavin solution is approximately 32 drops, or 1.6 ml (1 drop = 0.05 ml; 1.6 mL = 1.6 mg riboflavin).
| Study group | Role | What they receive |
|---|---|---|
| 9 mw/cm2 at 10 minutes group | Experimental | 30 patients will be treated with UVA light source at 9 mw/cm2 at 10 minutes. Drug: Riboflavin Dose:1 drop every 2 to 3 minutes for 15 to 20 minutes Receives: Device: UVA Light with irradiance exposure of 9 mW/cm2; Drug: Riboflavin 0.1% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Optical Aberrations of the Cornea following Cross-Linking
Assessment of changes in corneal curvature, as analyzed using a Pentacam Scheimpflug Analyzer will be used in all patients. This allows measurement of corneal thickness, maximum and minimum curvatures and aberration analysis of the cornea as an optical element. The most significant objective measure of change is the total Higher Order Aberrations of the cornea and the Kmax, or steepest curvature of the cornea. Analysis of corneal curvature is directly related to improvement in the corneal shape which is directly related to visual function.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study start1 Sep 2010
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 30 patients will be treated at 9 mw/cm2.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Trokel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephen Trokel, Columbia University
- Investigators
- Stephen Trokel, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789333
- Sponsor's protocol ID
- AAAF4157
- Status last verified
- Feb 2023
- First submitted
- 20 Nov 2012
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross- Linking at Higher Irradiances in Patients With Keratoconus or Ectasia
- ClinicalTrials.gov ID
- NCT01789333
- Acronym / sponsor ID
- AAAF4157
- Conditions
- Keratoconus, Ectasia
- Keywords
- Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK, irregular astigmatism
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stephen TrokelUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Feb 2013 (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 the study is to see if brighter lights will allow for shortening of the treatment time required to stabilize the eyes of patients with keratoconus or a bulging cornea. The investigators will be comparing the therapeutic effects of two different higher brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as bright as the other and the exposure time of these brighter lights to deliver equivalent energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes. Riboflavin is vitamin B2 and the investigators are trying to determine if an identical clinical effect can be achieved the brighter treatment lights are used for shorter times. The investigators will also monitor the clinical effect and the status of the cornea to see if additional risks are associated with the brighter light.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 30 patients will be treated at 9 mw/cm2.
| Arm | Type | Receives |
|---|---|---|
| 9 mw/cm2 at 10 minutes group | Experimental | Device: UVA Light with irradiance exposure of 9 mW/cm2, Drug: Riboflavin 0.1% ophthalmic solution30 patients will be treated with UVA light source at 9 mw/cm2 at 10 minutes. Drug: Riboflavin Dose:1 drop every 2 to 3 minutes for 15 to 20 minutes |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:
- 16 years of age or older
- Having a diagnosis of progressive keratoconus or pellucid marginal degeneration.
- The ability to sign a written informed consent
- States a willingness and ability to comply with schedule for follow-up visits
Key exclusion criteria (11 listed)
- Eyes classified as either normal or atypical normal,
- Corneal pachymetry ≤ 350 microns at the thinnest point in treatment zone measured by Pentacam.
- A history of delayed epithelial healing.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
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 |
|---|---|---|
| UVA Light with irradiance exposure of 9 mW/cm2The device's light emitting diode (LED) is used to deliver a metered dose of Ultraviolet A (UVA) light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking. The aperture setting will be set at 10 mm, and the eye will be irradiated for 10 minutes for the high irradiance exposure of 9 milliwatts (mW)/cm2. During the exposure, instillation of riboflavin will continue (1 drop every 3 minutes). | Device | 9 mw/cm2 at 10 minutes group |
| Riboflavin 0.1% ophthalmic solutionAlso: RiboflavinThe speculum is removed and one (1) drop of Riboflavin 0.1% ophthalmic solution will be instilled topically in the eye every 3 minutes for 30 minutes. At the end of the 30 minute riboflavin pre-treatment period, the eye will be examined to assure the presence of a yellow flare in the anterior chamber, indicating riboflavin saturation of the corneal tissue. If the yellow flare is not detected, riboflavin will continue to be instilled until the presence of the yellow flare in the anterior chamber is confirmed. During UVA irradiation, instillation of riboflavin will be continued every 3 minutes. For a 30-minute pre-treatment and 30-minute irradiation, the total dose of riboflavin solution is approximately 32 drops, or 1.6 ml (1 drop = 0.05 ml; 1.6 mL = 1.6 mg riboflavin). | Drug | 9 mw/cm2 at 10 minutes group |
Primary outcome
Change in Total Optical Aberrations of the Cornea following Cross-Linking
Time frame: Baseline to 6 months
Assessment of changes in corneal curvature, as analyzed using a Pentacam Scheimpflug Analyzer will be used in all patients. This allows measurement of corneal thickness, maximum and minimum curvatures and aberration analysis of the cornea as an optical element. The most significant objective measure of change is the total Higher Order Aberrations of the cornea and the Kmax, or steepest curvature of the cornea. Analysis of corneal curvature is directly related to improvement in the corneal shape which is directly related to visual function.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Stephen Trokel, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVA Light with irradiance exposure of 9 mW/cm2 and Riboflavin 0.1% ophthalmic solution in people with Keratoconus and Ectasia, run by Stephen Trokel 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 15 inclusion and 11 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: withdrawn, as of the sponsor's last update on 9 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 in Total Optical Aberrations of the Cornea following Cross-Linking (time frame: Baseline to 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 Feb 2023.