Trial Outcomes & Findings for Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia (NCT NCT01143389)
NCT ID: NCT01143389
Last Updated: 2018-06-06
Results Overview
Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
510 participants
Primary outcome timeframe
6 months
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
257
|
|
Overall Study
COMPLETED
|
227
|
232
|
|
Overall Study
NOT COMPLETED
|
26
|
25
|
Reasons for withdrawal
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
25
|
Baseline Characteristics
Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
Baseline characteristics by cohort
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
n=253 Participants
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).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
n=257 Participants
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).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Total
n=510 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 12 • n=5 Participants
|
32 years
STANDARD_DEVIATION 13 • n=7 Participants
|
32 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
215 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
253 participants
n=5 Participants
|
257 participants
n=7 Participants
|
510 participants
n=5 Participants
|
|
Keratoconus/ectasia classification
Keratoconus mild (flat K <51D and astigmatism <8D)
|
140 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Keratoconus/ectasia classification
Keratoconus moderate
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Keratoconus/ectasia classification
Keratoconus severe (flat K >56D by tomography)
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Keratoconus/ectasia classification
Ectasia after refractive surgery
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per protocol population
Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.
Outcome measures
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
n=227 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
n=232 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
|---|---|---|
|
Change in Maximum Keratometry From Baseline to 6 Months After Treatment
|
0.76 diopters
Standard Deviation 2.4
|
0.97 diopters
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol
Minimum corneal thickness measured by corneal tomography
Outcome measures
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
n=227 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
n=232 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
|---|---|---|
|
Pachymetry
|
438 microns
Standard Deviation 51
|
434 microns
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol
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.
Outcome measures
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
n=227 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
n=232 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
|---|---|---|
|
Corrected Distance Visual Acuity (CDVA)
|
0.32 logMAR
Standard Deviation 0.29
|
0.31 logMAR
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol
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.
Outcome measures
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
n=227 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
n=232 Participants
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
|---|---|---|
|
Uncorrected Distance Visual Acuity (UDVA)
|
0.95 logMAR
Standard Deviation 0.53
|
0.91 logMAR
Standard Deviation 0.55
|
Adverse Events
Riboflavin 0.1% Eyedrops Every 5 Minutes
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Riboflavin 0.1% Eyedrops Every 2 Minutes
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Riboflavin 0.1% Eyedrops Every 5 Minutes
n=253 participants at risk
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
Riboflavin 0.1% Eyedrops Every 2 Minutes
n=257 participants at risk
The eye will be irradiated for 30 minutes with UVX light, during which the instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Riboflavin: Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX light: UVX 365 nm wavelength light source is applied with continued application of riboflavin.
|
|---|---|---|
|
Eye disorders
Loss of 2 or more logMAR lines of corrected distance visual acuity (CDVA) relative to baseline
|
4.7%
12/253 • Number of events 12 • 6 months
|
5.1%
13/257 • Number of events 13 • 6 months
|
Additional Information
Marianne Price, PhD
Cornea Research Foundation of America
Phone: 317-814-2990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place