KeratoconusNCT01384773
Progressive Keratoconus or Ectasia Treatment Plan
A study testing Riboflavin Solution and UV-X Illumination System in people with Keratoconus and Ectasia, run by Stephen Trokel at 1 site in United States.
Trial summary
Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and post surgical ectasia is an iatrogenic condition. These diseases are characterized by weakening of the front part of the eye that causes thinning and distortion. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Ectasia
- What is being tested?
- Riboflavin Solution and UV-X Illumination System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects who have one or both eyes that meet all of the following criteria will be considered candidates for this treatment:
- For Keratoconus and Post Refractive Surgery Ectasia:
- 16 years of age or older
- Having a diagnosis of keratoconus with one or more of the following changes over a period of 24 months or less.
- An increase of > 1.00 D in the steepest keratometry value (or sim K)
- An increase of > 1.00 D in regular astigmatism evaluated by subjective manifest refraction
Show all 17Show fewer
- A myopic shift (decrease in the spherical equivalent) of > 0.50 D on subjective manifest refraction
- Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
- Presence of central or inferior steepening on the Pentacam map.
- Axial topography consistent with keratoconus
- Slit lamp findings associated with keratoconus must be documented:
- Fleischer ring
- Vogt striae
- Corneal thinning
- Corneal scarring
- Contact Lens Wearers Only: Removal of contact lenses are required prior to the screening
- Signed written informed consent
Who cannot join
- All subjects meeting any of the following criteria will be excluded from this treatment:
- No evidence of progression.
- Excessively thin corneas.
- Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- Clinically significant corneal scarring in the proposed treatment zone
Show all 9Show fewer
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- A known sensitivity to treatment medications
- Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.
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: Increasing CrossLinking of Corneal Collagen in Eyes With Progressive Keratoconus or Ectasia
Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and post surgical ectasia is an iatrogenic condition. These diseases are characterized by weakening of the front part of the eye that causes thinning and distortion. This distortion results in unevenness of the cornea and produces progressive near-sightedness and irregularity, which causes loss of vision when using eyeglasses. When eyeglasses fail to give enough vision, the the investigators use rigid contact lenses to create an artificial front eye surface. This improves visual acuity in many patients although they eventually fail either because they cannot be tolerated or the surface irregularity has become so severe that they are rejected. At this stage there is usually thinning and loss of clarity of the eye.
There has been no treatment for this other than corneal transplantation, a complex surgical procedure with a significant complication rate and a delay in visual recovery. The treatment the investigators wish to perform strengthens the front of the eye by a chemical reaction using light and riboflavin. This technique has been studied over a decade and is widely used throughout the world. The FDA approved multicenter American clinical study is being analyzed in anticipation of its submission to the FDA for PreMarket approval. Because this is a progressive condition, the investigators wish to be able to offer this on a limited basis to patients in need with vision loss.
Any treatment that can delay or prevent corneal transplantation is of great benefit. The investigators believe the evidence is compelling that this treatment is the sole alternative to surgical transplantation.
Read the detailed description
Potential candidates will undergo a complete eye examination to determine their eligibility for treatment. Eligible subjects will be prepared for treatment in accordance with the instructions for use in the UV-X™ Illumination System Operator's Manual, including the administration of the riboflavin and preoperative medications (e.g. topical anesthetics). Prescriptions for postoperative medications and written postoperative instructions will be given to each subject and reviewed prior to discharge. All subjects will have follow-up examination at 1 day, 1 week, 3 month and 6 month.
- Conditions
- Keratoconus, Ectasia
- Being tested
- Riboflavin Solution, UV-X Illumination System
- Keywords
- Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK (laser in situ keratomileusis), pellucid marginal degeneration, 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.
Riboflavin SolutionOther
Also called Medio-Cross Riboflavin 0.1% ophthalmic solution
This solution is used to saturate the corneal stroma prior to its photochemical activation by the IROC UV-X illuminator.
UV-X Illumination SystemDevice
Also called IROC UV-X System
IROC UV-X irradiation system creates a uniform 11 mm circle of UVA light that is focused onto the corneal surface. This system is designed to irradiate the riboflavin saturated cornea with a uniform field of UVA light centered at 365 nm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Stephen Trokel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephen Trokel, Columbia University
- Investigators
- Stephen L Trokel, MD, Principal investigator, Columbia University, Department of Ophthalmology, College of Physicians and Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384773
- Sponsor's protocol ID
- AAAF0594
- Status last verified
- Feb 2023
- First submitted
- 27 Jun 2011
- Last updated
- 9 Feb 2023
- Results posted
- No
Publications
Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. doi: 10.3928/1081597X-20080901-15.
PubMed 18811118
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
- Increasing CrossLinking of Corneal Collagen in Eyes With Progressive Keratoconus or Ectasia
- ClinicalTrials.gov ID
- NCT01384773
- Acronym / sponsor ID
- AAAF0594
- Conditions
- Keratoconus, Ectasia
- Keywords
- Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK (laser in situ keratomileusis), pellucid marginal degeneration, irregular astigmatism
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Stephen TrokelUniversity, hospital or other
- First posted
- 29 Jun 2011 (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.
Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and post surgical ectasia is an iatrogenic condition. These diseases are characterized by weakening of the front part of the eye that causes thinning and distortion. This distortion results in unevenness of the cornea and produces progressive near-sightedness and irregularity, which causes loss of vision when using eyeglasses. When eyeglasses fail to give enough vision, the the investigators use rigid contact lenses to create an artificial front eye surface. This improves visual acuity in many patients although they eventually fail either because they cannot be tolerated or the surface irregularity has become so severe that they are rejected. At this stage there is usually thinning and loss of clarity of the eye.
There has been no treatment for this other than corneal transplantation, a complex surgical procedure with a significant complication rate and a delay in visual recovery. The treatment the investigators wish to perform strengthens the front of the eye by a chemical reaction using light and riboflavin. This technique has been studied over a decade and is widely used throughout the world. The FDA approved multicenter American clinical study is being analyzed in anticipation of its submission to the FDA for PreMarket approval. Because this is a progressive condition, the investigators wish to be able to offer this on a limited basis to patients in need with vision loss.
Any treatment that can delay or prevent corneal transplantation is of great benefit. The investigators believe the evidence is compelling that this treatment is the sole alternative to surgical transplantation.
Detailed description
Potential candidates will undergo a complete eye examination to determine their eligibility for treatment. Eligible subjects will be prepared for treatment in accordance with the instructions for use in the UV-X™ Illumination System Operator's Manual, including the administration of the riboflavin and preoperative medications (e.g. topical anesthetics). Prescriptions for postoperative medications and written postoperative instructions will be given to each subject and reviewed prior to discharge. All subjects will have follow-up examination at 1 day, 1 week, 3 month and 6 month.
Study design
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects who have one or both eyes that meet all of the following criteria will be considered candidates for this treatment:
- 16 years of age or older
- Having a diagnosis of keratoconus with one or more of the following changes over a period of 24 months or less.
- Presence of central or inferior steepening on the Pentacam map.
- Axial topography consistent with keratoconus
Key exclusion criteria (9 listed)
- No evidence of progression.
- Excessively thin corneas.
- Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- A known sensitivity to treatment 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 |
|---|---|---|
| Riboflavin SolutionAlso: Medio-Cross Riboflavin 0.1% ophthalmic solutionThis solution is used to saturate the corneal stroma prior to its photochemical activation by the IROC UV-X illuminator. | Other | – |
| UV-X Illumination SystemAlso: IROC UV-X SystemIROC UV-X irradiation system creates a uniform 11 mm circle of UVA light that is focused onto the corneal surface. This system is designed to irradiate the riboflavin saturated cornea with a uniform field of UVA light centered at 365 nm. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 18811118Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. doi: 10.3928/1081597X-20080901-15.
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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 L Trokel, MD principal investigator
Columbia University, Department of Ophthalmology, College of Physicians and Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riboflavin Solution and UV-X Illumination System 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 17 inclusion and 9 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 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384773, which also lists 1 linked publication.
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.