Trial Outcomes & Findings for Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism (NCT NCT01496066)
NCT ID: NCT01496066
Last Updated: 2018-06-29
Results Overview
Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
COMPLETED
NA
600 participants
6 months
2018-06-29
Participant Flow
Participant milestones
| Measure |
LAL Implant
LAL implanted
LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD
|
Monofocal Control
Monofocal control IOL implanted
Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)
|
|---|---|---|
|
Overall Study
STARTED
|
403
|
197
|
|
Overall Study
COMPLETED
|
391
|
188
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
| Measure |
LAL Implant
LAL implanted
LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD
|
Monofocal Control
Monofocal control IOL implanted
Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
|
Overall Study
Explant
|
3
|
0
|
|
Overall Study
Death
|
1
|
4
|
Baseline Characteristics
Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
Baseline characteristics by cohort
| Measure |
LAL Implant
n=403 Participants
LAL implanted
LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD
|
Monofocal Control
n=197 Participants
Monofocal control IOL implanted
Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 7.9 • n=93 Participants
|
66.6 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
66.2 years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
344 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
256 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
385 Participants
n=93 Participants
|
190 Participants
n=4 Participants
|
575 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
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
383 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
571 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 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
|
|
Right Eye
|
226 Eyes
n=93 Participants
|
96 Eyes
n=4 Participants
|
322 Eyes
n=27 Participants
|
|
Left Eye
|
177 Eyes
n=93 Participants
|
101 Eyes
n=4 Participants
|
278 Eyes
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT. Only eyes that had cylinder in the range of treatment (\>=0.75 D) were included in the analysis. Therefore the number of participants analyzed for this outcome measure will not match the overall number of participants in the study.
Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=286 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
n=126 Participants
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Percent Reduction in Manifest Cylinder
|
74.6 percent reduction in manifest cylinder
Interval 71.1 to 78.1
|
19.9 percent reduction in manifest cylinder
Interval 10.9 to 28.9
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT. Any eyes that had an MRSE of zero at Pre-Adjustment were excluded since it is not possible to divide by zero. Therefore the number participants analyzed for this outcome will differ from the number of overall participants in the study.
Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=380 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
n=166 Participants
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Percent Absolute Reduction in MRSE
|
51.5 percentage of reduction in MRSE
Interval 43.8 to 59.1
|
10.4 percentage of reduction in MRSE
Interval -3.8 to 24.7
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT: The overall number of participants analyzed differs from the other outcome measures because some photographs were unusable due to inadequate lighting, user error, or equipment failure.
Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=358 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
|
96.1 percentage of eyes
Interval 93.5 to 97.8
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT
Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=391 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
n=193 Participants
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Uncorrected Visual Acuity 20/20 or Better
|
70.1 percentage of eyes
|
36.3 percentage of eyes
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment
Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=203 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
n=90 Participants
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
|
73.4 percent reduction in cylinder
Standard Deviation 33.1
|
18.6 percent reduction in cylinder
Standard Deviation 57.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with eyes in ITT with \>1.25 D of cylinder prior to light treatment
Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group.
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=83 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
n=36 Participants
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
|
77.5 percent reduction in cylinder
Standard Deviation 20.7
|
23.1 percent reduction in cylinder
Standard Deviation 32.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with eyes in ITT with \<0.75 D of cylinder prior to light treatment
For eyes with \<0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=100 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
n=53 Participants
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
|
55.2 percent absolute reduction in MRSE
Standard Deviation 76.3
|
27.2 percent absolute reduction in MRSE
Standard Deviation 75.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT population best case cohort with no macular problems
Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta).
Outcome measures
| Measure |
Light Adjustable Lens Implanted
n=390 Participants
Randomized to have the Light Adjustable Lens implanted
|
Control IOL Implanted
n=191 Participants
Randomized to have the monofocal control IOL implanted
|
|---|---|---|
|
Mean BSCVA
|
-0.066 LogMAR
Standard Deviation 0.083
|
-0.029 LogMAR
Standard Deviation 0.090
|
Adverse Events
Light Adjustable Lens
Monofocal Control IOL
Serious adverse events
| Measure |
Light Adjustable Lens
n=403 participants at risk
Randomized to have the Light Adjustable Lens implanted
|
Monofocal Control IOL
n=197 participants at risk
Randomized to have the Monofocal control IOL implanted
|
|---|---|---|
|
Eye disorders
Herpetic Keratouveitis
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Eye disorders
Persistent Induced Tritan Color Anomaly
|
0.50%
2/403 • Number of events 2 • 12 months
|
0.00%
0/197 • 12 months
|
|
Eye disorders
Cystoid Macular Edema
|
0.74%
3/403 • Number of events 3 • 12 months
|
1.5%
3/197 • Number of events 3 • 12 months
|
|
Eye disorders
Endophthalmitis
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Eye disorders
Horseshoe retinal tear with vitreous hemorrhage
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
Eye disorders
Hypopyon
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Eye disorders
Surgical complication
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Nervous system disorders
Anxiety
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Blood and lymphatic system disorders
Blood clots due to lymphoma
|
0.00%
0/403 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Vascular disorders
Broken blood vessel in brain
|
0.00%
0/403 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
General disorders
Broken wrist
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Cardiac disorders
Chest pain with pacemaker
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Cardiac disorders
Heart palpitations
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Cardiac disorders
Heart surgery
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Infections and infestations
Hospitalization due to cellulitis
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Injury, poisoning and procedural complications
Hospitalization due to concussion with subdural hematoma
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to emphysema/COPD
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Infections and infestations
Hospitalization due to infection after knee surgery
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
General disorders
Hospitalization due to syncope
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Gastrointestinal disorders
Hospitalization for colitis
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
General disorders
Hospitalization due to low blood pressure and syncope
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
General disorders
Hospitalization due to dizziness
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Renal and urinary disorders
Kidney disease
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver cancer
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neuroendocrine tumors
|
0.00%
0/403 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
Vascular disorders
Stroke
|
0.50%
2/403 • Number of events 2 • 12 months
|
0.00%
0/197 • 12 months
|
|
Vascular disorders
Transient ischemic attack
|
0.00%
0/403 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
Cardiac disorders
Triple bypass surgery
|
0.00%
0/403 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
Eye disorders
Secondary surgical intervention
|
1.7%
7/403 • Number of events 7 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
Eye disorders
Phytotoxic retinal damage causing temporary loss of BSCVA
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Eye disorders
Persistent induced erythropsia
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Eye disorders
Persistent unanticipated increase refractive error
|
1.2%
5/403 • Number of events 5 • 12 months
|
0.00%
0/197 • 12 months
|
|
Eye disorders
Intraoperative capsular tear
|
0.25%
1/403 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
Other adverse events
| Measure |
Light Adjustable Lens
n=403 participants at risk
Randomized to have the Light Adjustable Lens implanted
|
Monofocal Control IOL
n=197 participants at risk
Randomized to have the Monofocal control IOL implanted
|
|---|---|---|
|
Eye disorders
Anterior chamber cells
|
10.7%
43/403 • Number of events 43 • 12 months
|
10.7%
21/197 • Number of events 21 • 12 months
|
|
Eye disorders
Anterior chamber flare
|
4.7%
19/403 • Number of events 19 • 12 months
|
5.6%
11/197 • Number of events 11 • 12 months
|
|
Eye disorders
Blurred vision
|
7.7%
31/403 • Number of events 31 • 12 months
|
9.6%
19/197 • Number of events 19 • 12 months
|
|
Eye disorders
Corneal edema central
|
6.2%
25/403 • Number of events 25 • 12 months
|
6.6%
13/197 • Number of events 13 • 12 months
|
|
Eye disorders
corneal edema wound
|
10.7%
43/403 • Number of events 43 • 12 months
|
7.1%
14/197 • Number of events 14 • 12 months
|
|
Eye disorders
Posterior capsular opacity
|
12.7%
51/403 • Number of events 51 • 12 months
|
13.2%
26/197 • Number of events 26 • 12 months
|
|
Eye disorders
Raised IOP not requiring treatment
|
7.9%
32/403 • Number of events 32 • 12 months
|
1.0%
2/197 • Number of events 2 • 12 months
|
|
Eye disorders
Raised IOP requiring treatment
|
6.5%
26/403 • Number of events 26 • 12 months
|
7.1%
14/197 • Number of events 14 • 12 months
|
|
Eye disorders
Superficial punctate keratitis
|
5.5%
22/403 • Number of events 22 • 12 months
|
2.5%
5/197 • Number of events 5 • 12 months
|
Additional Information
Maureen O'Connell Vice President, Regulator and Clinical Affairs
RxSight, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place