Trial Outcomes & Findings for Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit (NCT NCT02863809)
NCT ID: NCT02863809
Last Updated: 2023-05-10
Results Overview
If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
76 participants
Primary outcome timeframe
2 years
Results posted on
2023-05-10
Participant Flow
76 subjects enrolled - signed consent form * 5 screen fails (did not meet eligibility criteria); * 1 withdrawal (signed consent form but declined to participate before randomization occurred) * 2 other (signed consent forms but were not able to receive surgery due to COVID-19 restrictions)
Participant milestones
| Measure |
Active Treatment Arm
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
Screen Fail (Post Randomization)
|
1
|
0
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Active Treatment Arm
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
Baseline characteristics by cohort
| Measure |
Active Treatment Arm
n=33 Participants
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 Participants
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 15.3 • n=93 Participants
|
62.8 years
STANDARD_DEVIATION 16.9 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 15.89 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Previous sterile keratolysis
|
28 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Autoimmune disease
Steven Johnson Syndrome
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Autoimmune disease
Rheumatoid Arthritis
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Autoimmune disease
Graft Versus Host Disease
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Autoimmune disease
Mucus Membrane Pemphigoid
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Autoimmune disease
Vogt-Koyangi-Harada Syndrome
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 yearsIf the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group.
Outcome measures
| Measure |
Active Treatment Arm
n=33 Participants
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 Participants
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Time From Surgery to Device Loss or Replacement
|
95 median weeks from surgery to removal
Interval 60.0 to 117.0
|
34 median weeks from surgery to removal
Interval 11.0 to 66.0
|
SECONDARY outcome
Timeframe: Twelve monthsThe number of participants that retained kpro devices at the end of twelve months will be studied and differences in retention rate between investigational and control groups will be reported
Outcome measures
| Measure |
Active Treatment Arm
n=33 Participants
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 Participants
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Number of Participants With Kpro Retention at 12 Months
|
29 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 30 daysThe number of incidences of delayed epithelial healing at day 30 will be recorded. If there is delayed epithelial healing at day 30 it will be determined if those incidences occurred more often in the control group versus the investigational group.
Outcome measures
| Measure |
Active Treatment Arm
n=33 Participants
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 Participants
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Number of Cumulative Delayed Epithelial Healing Events at Day 30
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 yearsIf follow up surgery is needed to replace or treat the prosthetic the time and reason will be recorded and the number of incidences will be compared between the study treatment groups
Outcome measures
| Measure |
Active Treatment Arm
n=33 Participants
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 Participants
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions)
|
300.3 median time (days) from surgery to RPM
Standard Deviation 194.7
|
253.37 median time (days) from surgery to RPM
Standard Deviation 158.11
|
SECONDARY outcome
Timeframe: 2 yearsThe time (days) and number of incidences of vitritis will be recorded for the subject in which it occurred and the number of incidences will be compared between the study treatment groups.
Outcome measures
| Measure |
Active Treatment Arm
n=33 Participants
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 Participants
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious)
|
188.6 median time (days) surgery to vitritis
Standard Deviation 218.4
|
254.3 median time (days) surgery to vitritis
Standard Deviation 239.6
|
Adverse Events
Active Treatment Arm
Serious events: 6 serious events
Other events: 17 other events
Deaths: 1 deaths
Control Treatment Arm
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Treatment Arm
n=34 participants at risk
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 participants at risk
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Eye disorders
Infection
|
5.9%
2/34 • Number of events 2 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Corneal Melt
|
5.9%
2/34 • Number of events 2 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
8.8%
3/34 • Number of events 3 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
High Intraocular Pressure
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 2 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Choroidal Detachment
|
2.9%
1/34 • Number of events 2 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Endophthalmitis
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Complication of corneal transplant
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Persistent Epithelial Defect
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Wound Dehiscence
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
Other adverse events
| Measure |
Active Treatment Arm
n=34 participants at risk
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
UVA Light Source: Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
|
Control Treatment Arm
n=34 participants at risk
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin: Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran: Dextran is used to increase the viscosity of the solution.
|
|---|---|---|
|
Eye disorders
Retroprosthetic Membrane
|
11.8%
4/34 • Number of events 4 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
8.8%
3/34 • Number of events 4 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Vitreous
|
5.9%
2/34 • Number of events 4 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
14.7%
5/34 • Number of events 5 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Corneal Thinning
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
5.9%
2/34 • Number of events 2 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
EPI Defect
|
8.8%
3/34 • Number of events 3 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
8.8%
3/34 • Number of events 4 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
High Intraocular Pressure
|
5.9%
2/34 • Number of events 2 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
5.9%
2/34 • Number of events 2 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Eye Pain (discomfort)
|
5.9%
2/34 • Number of events 4 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
8.8%
3/34 • Number of events 3 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Loose suture
|
5.9%
2/34 • Number of events 4 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
2.9%
1/34 • Number of events 1 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
|
Eye disorders
Hemmorrge
|
8.8%
3/34 • Number of events 3 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
0.00%
0/34 • Day 1, Week 1, Week 4, Week 16, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182
Adverse Event - Any untoward or unfavorable medical occurrence in a human subject. Only adverse events that met a frequency threshold of 5% have been reported to CT.gov (occurred in greater than 5% of the study participants). Serious Adverse Event - For this study, a Serious Adverse Event is defined as any event temporally associated with the subject's participation in research that results in death; is life threatening; requires hospitalization;
|
Additional Information
Odeta Dyrmishi & Joseph Ciolino
Massachusetts Eye and Ear
Phone: 7742745014
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place