Trial Outcomes & Findings for Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism (NCT NCT03729024)
NCT ID: NCT03729024
Last Updated: 2021-08-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2021-08-06
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
|
|---|---|
|
Overall Study
STARTED
|
21 42
|
|
Overall Study
COMPLETED
|
21 42
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism
Baseline characteristics by cohort
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=42 Eyes
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
|
|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=42 Eyes
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
|
|---|---|
|
Percent of Eyes With UCDVA of 20/20 or Better
|
41 Eyes
|
Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
n=42 participants at risk
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
|
|---|---|
|
Eye disorders
Cystoid Macular Edema
|
2.4%
1/42 • Number of events 1 • Through study completion, an average of 6 months
The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
|
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