Trial Outcomes & Findings for Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL) (NCT NCT00845520)
NCT ID: NCT00845520
Last Updated: 2018-07-06
Results Overview
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
6 months post-operative
Results posted on
2018-07-06
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Lens Implant Power +1.00 D Target
Lens implant power +1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative +1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
|
Lens Implant Power -1.00 D Target
Lens implant power -1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative -1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
|
Lens Implant Power 0.00 D Target
Lens implant power 0.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative 0.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25 25
|
25 25
|
24 24
|
|
Overall Study
COMPLETED
|
23 23
|
23 23
|
23 23
|
|
Overall Study
NOT COMPLETED
|
2 2
|
2 2
|
1 1
|
Reasons for withdrawal
| Measure |
Lens Implant Power +1.00 D Target
Lens implant power +1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative +1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
|
Lens Implant Power -1.00 D Target
Lens implant power -1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative -1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
|
Lens Implant Power 0.00 D Target
Lens implant power 0.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative 0.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)
Baseline characteristics by cohort
| Measure |
Lens Implant Power +1.00 D Target
n=25 Participants
The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 diopter
|
Lens Implant Power 0.00 D Target
n=24 Participants
The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 diopter
|
Lens Implant Power -1.00 D Target
n=25 Participants
The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 11.00 diopter
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months post-operativePopulation: ITT
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
Outcome measures
| Measure |
Lens Implant Power -1.00 D Target
n=23 Participants
Eyes randomized to a target lens implant power of -1.00 D
|
Lens Implant Power +1.00 D Target
n=25 Participants
Eyes randomized to a target lens implant power of +1.00 D
|
Lens Implant Power 0.00 D Target
n=24 Participants
Eyes randomized to a target lens implant power of 0.00 D
|
|---|---|---|---|
|
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
|
78.3 percentage of eyes
|
80.0 percentage of eyes
|
79.2 percentage of eyes
|
SECONDARY outcome
Timeframe: 6 months post operativePopulation: Participants with eyes with UCVA of 20/50 or worse UCVA prior to light treatment
Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.
Outcome measures
| Measure |
Lens Implant Power -1.00 D Target
n=10 Participants
Eyes randomized to a target lens implant power of -1.00 D
|
Lens Implant Power +1.00 D Target
n=1 Participants
Eyes randomized to a target lens implant power of +1.00 D
|
Lens Implant Power 0.00 D Target
n=1 Participants
Eyes randomized to a target lens implant power of 0.00 D
|
|---|---|---|---|
|
Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
|
77.8 percentage of eyes
|
100 percentage of eyes
|
0 percentage of eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: All available eyes at 12 months. The overall number of participants for this outcome measures differs the previously stated overall number of 74 because two subjects were deceased at their 12 month post-operative follow up visit.
Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.
Outcome measures
| Measure |
Lens Implant Power -1.00 D Target
n=23 Participants
Eyes randomized to a target lens implant power of -1.00 D
|
Lens Implant Power +1.00 D Target
n=24 Participants
Eyes randomized to a target lens implant power of +1.00 D
|
Lens Implant Power 0.00 D Target
n=25 Participants
Eyes randomized to a target lens implant power of 0.00 D
|
|---|---|---|---|
|
Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better
|
100 percentage of eyes
|
100 percentage of eyes
|
100 percentage of eyes
|
Adverse Events
Lens Implant Power of +1.00 D Target
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Lens Implant Power of -1.00 D Target
Serious events: 2 serious events
Other events: 15 other events
Deaths: 2 deaths
Lens Implant Power of 0.00 D
Serious events: 1 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Lens Implant Power of +1.00 D Target
n=25 participants at risk
Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 D
|
Lens Implant Power of -1.00 D Target
n=25 participants at risk
Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of -1.00 D
|
Lens Implant Power of 0.00 D
n=24 participants at risk
Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 D
|
|---|---|---|---|
|
Eye disorders
Secondary Surgical Intervention
|
4.0%
1/25 • Number of events 1 • 36 months
|
4.0%
1/25 • Number of events 1 • 36 months
|
4.2%
1/24 • Number of events 1 • 36 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/25 • 36 months
|
4.0%
1/25 • Number of events 1 • 36 months
|
0.00%
0/24 • 36 months
|
|
Eye disorders
Optic neuritis
|
4.0%
1/25 • Number of events 1 • 36 months
|
0.00%
0/25 • 36 months
|
0.00%
0/24 • 36 months
|
|
Eye disorders
epiretinal membrane and macular hole
|
0.00%
0/25 • 36 months
|
0.00%
0/25 • 36 months
|
4.2%
1/24 • Number of events 1 • 36 months
|
|
Eye disorders
wet age related macular degeneration
|
0.00%
0/25 • 36 months
|
4.0%
1/25 • Number of events 1 • 36 months
|
0.00%
0/24 • 36 months
|
|
Eye disorders
macular edema secondary to epiretinal membrate
|
4.0%
1/25 • Number of events 1 • 36 months
|
0.00%
0/25 • 36 months
|
0.00%
0/24 • 36 months
|
|
Cardiac disorders
heart attack with pacemaker implanted
|
0.00%
0/25 • 36 months
|
0.00%
0/25 • 36 months
|
4.2%
1/24 • Number of events 1 • 36 months
|
Other adverse events
| Measure |
Lens Implant Power of +1.00 D Target
n=25 participants at risk
Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 D
|
Lens Implant Power of -1.00 D Target
n=25 participants at risk
Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of -1.00 D
|
Lens Implant Power of 0.00 D
n=24 participants at risk
Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 D
|
|---|---|---|---|
|
Eye disorders
Posterior Capsular Opacity
|
68.0%
17/25 • Number of events 33 • 36 months
|
60.0%
15/25 • Number of events 37 • 36 months
|
54.2%
13/24 • Number of events 30 • 36 months
|
|
Eye disorders
Blepharitis
|
4.0%
1/25 • Number of events 3 • 36 months
|
4.0%
1/25 • Number of events 1 • 36 months
|
8.3%
2/24 • Number of events 2 • 36 months
|
Additional Information
Maureen O'Connell Vice President, Regulator and Clinical Affairs
RxSight, Inc.
Phone: 978-207-12415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place