A Phase 2 interventional study of Riboflavin and UVX light in Keratoconus and Post-Refractive Ectasia, sponsored by Price Vision Group. Completed at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Price Vision Group · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.
The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 510 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Price Vision Group is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:
Subjects with keratoconus diagnosis only:
a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring
Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
Exclusion Criteria:
Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.
a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Drug: Riboflavin · Device: UVX light
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Drug: Riboflavin · Device: UVX light
Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX 365 nm wavelength light source is applied with continued application of riboflavin.
Change in Maximum Keratometry From Baseline to 6 Months After Treatment
Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.
Time frame: 6 months
Pachymetry
Minimum corneal thickness measured by corneal tomography
Time frame: 6 months
Corrected Distance Visual Acuity (CDVA)
Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
Time frame: 6 months
Uncorrected Distance Visual Acuity (UDVA)
Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
Time frame: 6 months
| Milestone | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes |
|---|---|---|
| Started | 253 | 257 |
| Completed | 227 | 232 |
| Not completed | 26 | 25 |
| Withdrew: Lost to follow-up | 26 | 25 |
Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.
| diopters | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes |
|---|---|---|
| Change in Maximum Keratometry From Baseline to 6 Months After Treatment | 0.76 ± 2.4 | 0.97 ± 3.2 |
Minimum corneal thickness measured by corneal tomography
| microns | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes |
|---|---|---|
| Pachymetry | 438 ± 51 | 434 ± 20 |
Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
| logMAR | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes |
|---|---|---|
| Corrected Distance Visual Acuity (CDVA) | 0.32 ± 0.29 | 0.31 ± 0.28 |
Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
| logMAR | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes |
|---|---|---|
| Uncorrected Distance Visual Acuity (UDVA) | 0.95 ± 0.53 | 0.91 ± 0.55 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Riboflavin 0.1% Eyedrops Every 5 Minutes | 0/253 (0%) | 0/253 (0%) | 12/253 (4.7%) |
| Riboflavin 0.1% Eyedrops Every 2 Minutes | 0/257 (0%) | 0/257 (0%) | 13/257 (5.1%) |
| Event | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes |
|---|---|---|
| Loss of 2 or more logMAR lines of corrected distance visual acuity (CDVA) relative to baselineEye disorders | 12/253 | 13/257 |
| Age, Continuous(years) | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes | Total |
|---|---|---|---|
| Mean | 32 ± 12 | 32 ± 13 | 32 ± 13 |
| Sex: Female, Male(Participants) | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes | Total |
|---|---|---|---|
| Female | 62 | 61 | 123 |
| Male | 191 | 196 | 387 |
| Race (NIH/OMB)(Participants) | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 13 | 23 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 28 | 24 | 52 |
| White | 215 | 220 | 435 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes | Total |
|---|---|---|---|
| United States | 253 | 257 | 510 |
| Keratoconus/ectasia classification(Participants) | Riboflavin 0.1% Eyedrops Every 5 Minutes | Riboflavin 0.1% Eyedrops Every 2 Minutes | Total |
|---|---|---|---|
| Keratoconus mild (flat K <51D and astigmatism <8D) | 140 | 139 | 279 |
| Keratoconus moderate | 43 | 43 | 86 |
| Keratoconus severe (flat K >56D by tomography) | 20 | 21 | 41 |
| Ectasia after refractive surgery | 50 | 54 | 104 |
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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