Trial Outcomes & Findings for Transepithelial Corneal Cross-linking Using Iontophoresis (NCT NCT02117999)
NCT ID: NCT02117999
Last Updated: 2019-08-08
Results Overview
Measuring maximum keratometry (K-max), measured in diopters (D), derived from computerized videokeratography.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Changes from baseline in Kmax at 12 months
Results posted on
2019-08-08
Participant Flow
Eligible patients were randomized after enrolment, with allocation ratio of 2:1, into either the study or control group
Block randomization strategy was used to randomize units with comparable baseline Kmax values in either group.
Unit of analysis: eyes
Participant milestones
| Measure |
T-ionto CL
Eyes undergoing transepithelial corneal cross-linking with iontophoresis
|
Standard CL
Eyes undergoing standard corneal cross-linking
|
|---|---|---|
|
Overall Study
STARTED
|
20 22
|
10 12
|
|
Overall Study
Mean Kmax Change in Corneal Topography
|
20 22
|
10 12
|
|
Overall Study
COMPLETED
|
20 22
|
10 12
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transepithelial Corneal Cross-linking Using Iontophoresis
Baseline characteristics by cohort
| Measure |
Standard CL
n=12 eyes
Participants undergoing standard corneal cross-linking
|
T-ionto CL
n=22 eyes
Participants undergoing transepithelial corneal cross-linking with iontophoresis
|
Total
n=34 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
31 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
30 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 eyes
n=32 eyes
|
3 eyes
n=16 eyes
|
7 eyes
n=48 eyes
|
|
Sex: Female, Male
Male
|
8 eyes
n=32 eyes
|
19 eyes
n=16 eyes
|
27 eyes
n=48 eyes
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 eyes
n=32 eyes
|
22 eyes
n=16 eyes
|
34 eyes
n=48 eyes
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Race (NIH/OMB)
Asian
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Race (NIH/OMB)
Black or African American
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Race (NIH/OMB)
White
|
12 eyes
n=32 eyes
|
22 eyes
n=16 eyes
|
34 eyes
n=48 eyes
|
|
Race (NIH/OMB)
More than one race
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
0 eyes
n=48 eyes
|
|
Region of Enrollment
Italy
|
12 eyes
n=32 eyes
|
22 eyes
n=16 eyes
|
34 eyes
n=48 eyes
|
|
family history of keratoconus
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline in Kmax at 12 monthsPopulation: Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.
Measuring maximum keratometry (K-max), measured in diopters (D), derived from computerized videokeratography.
Outcome measures
| Measure |
Transepithelial Corneal Cross-linking Using Iontophoresis
n=22 Participants
Transepithelial corneal cross-linking using iontophoresis
Transepithelial corneal cross-linking using iontophoresis: The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.
|
Standard Corneal Cross-linking
n=12 Participants
Standard corneal cross-linking
Standard corneal cross-linking: In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.
|
|---|---|---|
|
K-max
|
-0.52 Diopters (D)
Standard Deviation 1.30
|
-0.82 Diopters (D)
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: Changes from baseline in ECD at 12 monthsPopulation: Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.
Endothelial cell density (ECD) will be evaluated using specular microscopy
Outcome measures
| Measure |
Transepithelial Corneal Cross-linking Using Iontophoresis
n=22 Participants
Transepithelial corneal cross-linking using iontophoresis
Transepithelial corneal cross-linking using iontophoresis: The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.
|
Standard Corneal Cross-linking
n=12 Participants
Standard corneal cross-linking
Standard corneal cross-linking: In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.
|
|---|---|---|
|
Corneal Endothelial Cell Density
|
2675 cells/mm2
Standard Deviation 311
|
2658 cells/mm2
Standard Deviation 321
|
SECONDARY outcome
Timeframe: Changes from baseline at 12 months.Population: Corneal high-order aberrations
Optical aberrations of the eye will be measured using dynamic skyascopy. Corneal wavefront aberration will be measured using Placido disk topographer and Scheimpflug tomographer.
Outcome measures
| Measure |
Transepithelial Corneal Cross-linking Using Iontophoresis
n=20 Participants
Transepithelial corneal cross-linking using iontophoresis
Transepithelial corneal cross-linking using iontophoresis: The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.
|
Standard Corneal Cross-linking
n=10 Participants
Standard corneal cross-linking
Standard corneal cross-linking: In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.
|
|---|---|---|
|
Optical Aberrations
|
2.19 micrometers
Standard Deviation 0.99
|
2.21 micrometers
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Changes from baseline at 12 months.Population: Corrected distance visual acuity
Visual acuity tested using ETDRS
Outcome measures
| Measure |
Transepithelial Corneal Cross-linking Using Iontophoresis
n=20 Participants
Transepithelial corneal cross-linking using iontophoresis
Transepithelial corneal cross-linking using iontophoresis: The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.
|
Standard Corneal Cross-linking
n=10 Participants
Standard corneal cross-linking
Standard corneal cross-linking: In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.
|
|---|---|---|
|
Visual Acuity
|
0.03 LogMAR
Standard Deviation 0.10
|
0.01 LogMAR
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Changes from baseline at 12 months.Population: Contrast-sensitivity function assessed by Pelli-Robson charts
Contrast sensitivity tested using Pelli-Robson chart
Outcome measures
| Measure |
Transepithelial Corneal Cross-linking Using Iontophoresis
n=20 Participants
Transepithelial corneal cross-linking using iontophoresis
Transepithelial corneal cross-linking using iontophoresis: The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.
|
Standard Corneal Cross-linking
n=10 Participants
Standard corneal cross-linking
Standard corneal cross-linking: In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.
|
|---|---|---|
|
Contrast Sensitivity
|
1.62 log
Standard Deviation 0.08
|
1.63 log
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Changes from baseline at 12 months.Population: 1 mm central retinal thickness assessed by SD-OCT
Central retinal thickness (1 mm ETDRS map) will be measured before and after CXL procedures
Outcome measures
| Measure |
Transepithelial Corneal Cross-linking Using Iontophoresis
n=20 Participants
Transepithelial corneal cross-linking using iontophoresis
Transepithelial corneal cross-linking using iontophoresis: The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.
|
Standard Corneal Cross-linking
n=10 Participants
Standard corneal cross-linking
Standard corneal cross-linking: In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.
|
|---|---|---|
|
Central Retinal Thickness
|
275 micrometers
Standard Deviation 20
|
277 micrometers
Standard Deviation 38
|
Adverse Events
Transepithelial Corneal Cross-linking Using Iontophoresis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Corneal Cross-linking
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transepithelial Corneal Cross-linking Using Iontophoresis
n=20 participants at risk
Participants undergoing transepithelial corneal cross-linking using iontophoresis
|
Standard Corneal Cross-linking
n=10 participants at risk
Participants undergoing standard corneal cross-linking
|
|---|---|---|
|
Eye disorders
Corneal sub-epithelial infiltrates
|
0.00%
0/20 • 1 year
no differences
|
10.0%
1/10 • Number of events 1 • 1 year
no differences
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place