Trial Outcomes & Findings for Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery (NCT NCT03660865)
NCT ID: NCT03660865
Last Updated: 2021-12-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Postop Month 6
Results posted on
2021-12-23
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
Overall Study
STARTED
|
105 105
|
105 105
|
|
Overall Study
COMPLETED
|
105 105
|
105 105
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
Baseline characteristics by cohort
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
Total
n=210 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 6.9 • n=14 Eyes
|
64.2 years
STANDARD_DEVIATION 6.9 • n=23 Eyes
|
64.2 years
STANDARD_DEVIATION 6.9 • n=50 Eyes
|
|
Sex: Female, Male
Female
|
60 Eyes
n=14 Eyes
|
60 Eyes
n=23 Eyes
|
120 Eyes
n=50 Eyes
|
|
Sex: Female, Male
Male
|
45 Eyes
n=14 Eyes
|
45 Eyes
n=23 Eyes
|
90 Eyes
n=50 Eyes
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Eyes
n=14 Eyes
|
12 Eyes
n=23 Eyes
|
24 Eyes
n=50 Eyes
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Eyes
n=14 Eyes
|
93 Eyes
n=23 Eyes
|
186 Eyes
n=50 Eyes
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Asian
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Black or African American
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
White
|
105 Eyes
n=14 Eyes
|
105 Eyes
n=23 Eyes
|
210 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
More than one race
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Region of Enrollment
United States
|
105 Eyes
n=14 Eyes
|
105 Eyes
n=23 Eyes
|
210 Eyes
n=50 Eyes
|
|
Eye
OD Eye
|
52 Eyes
n=14 Eyes
|
53 Eyes
n=23 Eyes
|
105 Eyes
n=50 Eyes
|
|
Eye
OS Eye
|
53 Eyes
n=14 Eyes
|
52 Eyes
n=23 Eyes
|
105 Eyes
n=50 Eyes
|
PRIMARY outcome
Timeframe: Postop Month 6Outcome measures
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
|
-0.319 Diopter
Standard Deviation 0.319
|
-0.452 Diopter
Standard Deviation 0.456
|
PRIMARY outcome
Timeframe: Postop Month 6Outcome measures
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
|
0.269 Diopter
Standard Deviation 0.269
|
0.379 Diopter
Standard Deviation 0.338
|
PRIMARY outcome
Timeframe: Postop Month 6Outcome measures
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
|
100 percent of eyes w. BCDVA 20/40 or better
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Postop Month 6Outcome measures
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
n=105 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
Uncorrected Distance Visual Acuity (UCDVA)
|
0.002 logMAR
Standard Deviation 0.108
|
0.052 logMAR
Standard Deviation 0.130
|
SECONDARY outcome
Timeframe: Postop Month 6Outcome measures
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=42 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
n=42 Eyes
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
|
-0.003 mean logMAR UCDVA
Standard Deviation 0.113
|
0.061 mean logMAR UCDVA
Standard Deviation 0.139
|
Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Control IOL
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=105 participants at risk
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
n=105 participants at risk
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
Eye disorders
Clinically significant Cystoid Macular Edema
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Secondary Surgical Intervention (excluding Posterior Capsulotomy)
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
Other adverse events
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=105 participants at risk
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
|
Control IOL
n=105 participants at risk
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL
|
|---|---|---|
|
Eye disorders
Anterior Chamber Inflammation
|
1.9%
2/105 • Number of events 2 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
1.9%
2/105 • Number of events 2 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Corneal Edema
|
1.9%
2/105 • Number of events 2 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Loss of BCDVA of >/= 10 letters (when compared to Preoperative or Postop Week 3 BCDVA)
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Removal of retained Cortex
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Conjunctival hyperemia
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Conjunctival hyperemia/edema
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Corneal SPK
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Double vision
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Epithelial basement membrane dystrophy appearance
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Epithelial defect
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
1.9%
2/105 • Number of events 2 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Glare at night
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Iris atrophy/Medication deposits
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Iris prolapse
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Light sensitivity
|
1.9%
2/105 • Number of events 2 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
1.9%
2/105 • Number of events 2 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Non-clinically significant cystoid macular edema
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Ocular discomfort
|
2.9%
3/105 • Number of events 3 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Posterior vitreous detachment
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Retained cortex
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Vision doesn't fuse together for distance well
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
Vitreous in anterior chamber
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
YAG performed to treat capsular phemosis
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
YAG performed to treat capsular striae
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.00%
0/105 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
YAG performed to treat posterior capsular opacity
|
25.7%
27/105 • Number of events 27 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
19.0%
20/105 • Number of events 20 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
|
Eye disorders
YAG performed to treat vitreous strand
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
0.95%
1/105 • Number of events 1 • Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
|
Additional Information
Jeffrey Ha, Senior Director of Clinical Research
RxSight
Phone: 949-521-7870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place