Trial Outcomes & Findings for Theranostic Guided Riboflavin/UV-A Corneal Cross-linking (NCT NCT05457647)
NCT ID: NCT05457647
Last Updated: 2025-02-11
Results Overview
The aim of this study is to validate the combined use of theranostic imaging biomarkers in predicting the propsensity of corneal corneal cross-linking (CXL) in flattening the Kmax at 1-year. The accuracy and precision (95% CI) of the combined use of the theranostic imaging biomarkers to predict CXL treatment outcome are determined by calculating the percentage of correctly classified eyes and the positive predictive value (PPV) respectively.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
12 months
Results posted on
2025-02-11
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Overall Study
STARTED
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50 50
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Overall Study
COMPLETED
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47 47
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Overall Study
NOT COMPLETED
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3 3
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Reasons for withdrawal
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Overall Study
Lost to Follow-up
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3
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Baseline Characteristics
Theranostic Guided Riboflavin/UV-A Corneal Cross-linking
Baseline characteristics by cohort
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=50 Participants
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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|---|---|
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Age, Continuous
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26 years
STANDARD_DEVIATION 5 • n=5 Participants
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Sex: Female, Male
Female
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13 Participants
n=5 Participants
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Sex: Female, Male
Male
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37 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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50 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Italy
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50 participants
n=5 Participants
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|
Medical history
Positive family history of keratoconus
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12 participants
n=5 Participants
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Medical history
History of allergy/dermatitis
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4 participants
n=5 Participants
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Medical history
History of hypothyroidism
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3 participants
n=5 Participants
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Medical history
History of diabetes mellitus
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1 participants
n=5 Participants
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Medical history
History of systemic lupus erythematosus and ulcerative colitis
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1 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 12 monthsThe aim of this study is to validate the combined use of theranostic imaging biomarkers in predicting the propsensity of corneal corneal cross-linking (CXL) in flattening the Kmax at 1-year. The accuracy and precision (95% CI) of the combined use of the theranostic imaging biomarkers to predict CXL treatment outcome are determined by calculating the percentage of correctly classified eyes and the positive predictive value (PPV) respectively.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=47 Eyes
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Validation of the Theranostic Scores
Accuracy
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91 Percentage
Interval 79.0 to 98.0
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—
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Validation of the Theranostic Scores
Precision
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95 Percentage
Interval 89.0 to 99.0
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—
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SECONDARY outcome
Timeframe: 12 monthsChange of Maximum Keratometry value of Placido disc corneal topography. The secondary outcome measure of efficacy was assessed by measuring changes of Kmax value (D) from baseline to 12 months postoperatively.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=47 Eyes
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
|
Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Corneal Topography
|
-1.5 diopters
Standard Deviation 1.6
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—
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SECONDARY outcome
Timeframe: 12 monthsChange of Endothelial Cell Density (ECD) of the cornea. The secondary outcome measure of safety was assessed by measuring change of ECD (cell/mm\^2) from baseline to 12 months postoperatively.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=47 Eyes
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
|
Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Endothelial Cell Density
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-63 cells/mm^2
Standard Deviation 336
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsChange of Manifest Spherical Equivalent Refraction (MSER). This outcome was assessed by measuring change of MSER (D) from baseline to 12 months postoperatively.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=47 Participants
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
|
Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Manifest Refraction
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0.2 diopters
Standard Deviation 1.2
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsChange of Corrected Distance Visual Acuity (CDVA) measured with ETDRS chart and expressed in LogMAR. This outcome was assessed by measuring changes of CDVA from baseline to 12 months postoperatively. A negative change means improvement in CDVA after treatment.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=47 Eyes
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
|
Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Corrected Distance Visual Acuity
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-0.1 LogMAR
Standard Deviation 0.1
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsChange of Uncorrected Distance Visual Acuity (UDVA) measured with ETDRS chart and expressed in LogMAR. This outcome was assessed by measuring changes of UDVA from baseline to 12 months postoperatively. A negative change means improvement in UDVA after treatment.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=47 Eyes
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
|
Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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Uncorrected Distance Visual Acuity
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-0.1 LogMAR
Standard Deviation 0.1
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—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsChange of Central Corneal Thickness (CCT). This outcome was assessed by measuring changes of CCT from baseline to 12 months postoperatively.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=47 Eyes
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
|
Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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|---|---|---|
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Central Corneal Thickness
|
-5 micrometers
Standard Deviation 18
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsChange of primary and secondary outcome measures in either stratification group (epi-off CXL protocol and epi-on CXL protocol). These exploratory outcome measures included the following assessment: assessmentg of changes of Kmax value (D) at 12-months postoperatively in either stratification group.
Outcome measures
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=24 Eyes
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, Epi-OFF, or transepithelial, Epi-ON, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the EpiOFF CXL treatment and 20 minutes for the EpiON CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
|
Epi-on Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=23 Eyes
Stratification arm receiving riboflavin/UV-A corneal cross-linking with epi-on treatment protocol. Only one eye of each participant is designated as the study eye.
Participants receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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|---|---|---|
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Stratification Groups
|
-1.9 diopters
Standard Deviation 2.0
|
-1.1 diopters
Standard Deviation 1.0
|
Adverse Events
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Riboflavin/UV-A Corneal Cross-linking Monitored by Theranostic Software Module
n=50 participants at risk
One study arm receiving riboflavin/UV-A corneal cross-linking with either standard, epi-off, or transepithelial, epi-on, treatment protocol. Only one eye of each participant is designated as the study eye.
Riboflavin/UV-A corneal cross-linking: corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ system equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the epi-off CXL treatment and 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A irradiation.
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|---|---|
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Eye disorders
Corneal Haze
|
12.0%
6/50 • 1-week, 1-month, 3-months, 6-months and 12-months,.
Corneal haze was the only adverse events recorded.
|
Additional Information
Dr. Marco Lombardo, Study Director
Studio Italiano di Oftalmologia
Phone: +393313438300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place