Cataract
Conditions
Brief summary
The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.
Interventions
DEVICELAL (Light Adjustable Lens) and Light Deliver Device (LDD)
LAL implanted and adjusted with LDD
DEVICEMonofocal control IOL
Commercially available monofocal intraocular lens (IOL)
Sponsors
Calhoun Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Phase 3 medical device study
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted * Pre-operative regular corneal astigmatism of \>= 0.75 diopters and \<= 2.0 diopters * Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare * Projected best spectacle corrected visual acuity of 20/20 or better * Clear intraocular media other than cataract * Potentially good vision in fellow eye * Fully dilated pupil of \>= 7.0 mm
Exclusion criteria
* Zonular laxity or dehiscence * Pseudoexfoliation * Age related macular degeneration * Retinal degenerative disorder * Diabetes with any evidence of retinopathy * Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus * Corneal dystrophy, previous corneal or intraocular surgery * Complications during cataract surgery * Serious co-morbid conditions * Systemic medications that my increase UV sensitivity * Irregular astigmatism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Reduction in Manifest Cylinder | 6 months | 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. |
| Percent Absolute Reduction in MRSE | 6 months | 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. |
| Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively | 6 months | 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. |
| Uncorrected Visual Acuity 20/20 or Better | 6 months | 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. |
| Mean BSCVA | 6 months | 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). |
| Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) | 6 months | 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. |
| Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LAL Implant LAL implanted
LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD | 403 |
| Monofocal Control Monofocal control IOL implanted
Monofocal control IOL: Commercially available monofocal intraocular lens (IOL) | 197 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 4 |
| Overall Study | Explant | 3 | 0 |
| Overall Study | Lost to Follow-up | 8 | 5 |
Baseline characteristics
| Characteristic | LAL Implant | Monofocal Control | Total |
|---|---|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 7.9 | 66.6 years STANDARD_DEVIATION 7.2 | 66.2 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 7 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 385 Participants | 190 Participants | 575 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Left Eye | 177 Eyes | 101 Eyes | 278 Eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 6 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 383 Participants | 188 Participants | 571 Participants |
| Right Eye | 226 Eyes | 96 Eyes | 322 Eyes |
| Sex: Female, Male Female | 242 Participants | 102 Participants | 344 Participants |
| Sex: Female, Male Male | 161 Participants | 95 Participants | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 403 | 4 / 197 |
| other Total, other adverse events | 292 / 403 | 125 / 197 |
| serious Total, serious adverse events | 42 / 403 | 10 / 197 |
Outcome results
Primary
Percent Absolute Reduction in MRSE
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Light Adjustable Lens Implanted | Percent Absolute Reduction in MRSE | 51.5 percentage of reduction in MRSE |
| Control IOL Implanted | Percent Absolute Reduction in MRSE | 10.4 percentage of reduction in MRSE |
Primary
Percent Reduction in Manifest Cylinder
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Light Adjustable Lens Implanted | Percent Reduction in Manifest Cylinder | 74.6 percent reduction in manifest cylinder |
| Control IOL Implanted | Percent Reduction in Manifest Cylinder | 19.9 percent reduction in manifest cylinder |
Primary
Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Light Adjustable Lens Implanted | Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop | 96.1 percentage of eyes |
Secondary
Mean BSCVA
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).
Time frame: 6 months
Population: ITT population best case cohort with no macular problems
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens Implanted | Mean BSCVA | -0.066 LogMAR | Standard Deviation 0.083 |
| Control IOL Implanted | Mean BSCVA | -0.029 LogMAR | Standard Deviation 0.09 |
99% CI: [-0.06, -0.02]
Secondary
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
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.
Time frame: 6 months
Population: Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens Implanted | Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) | 73.4 percent reduction in cylinder | Standard Deviation 33.1 |
| Control IOL Implanted | Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) | 18.6 percent reduction in cylinder | Standard Deviation 57 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
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.
Time frame: 6 months
Population: Participants with eyes in ITT with \>1.25 D of cylinder prior to light treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens Implanted | Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) | 77.5 percent reduction in cylinder | Standard Deviation 20.7 |
| Control IOL Implanted | Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) | 23.1 percent reduction in cylinder | Standard Deviation 32.3 |
p-value: <0.0001t-test, 2 sided
Secondary
Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
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.
Time frame: 6 months
Population: Participants with eyes in ITT with \<0.75 D of cylinder prior to light treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens 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 |
| Control IOL Implanted | Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively | 27.2 percent absolute reduction in MRSE | Standard Deviation 75.2 |
p-value: 0.0318t-test, 2 sided
Secondary
Uncorrected Visual Acuity 20/20 or Better
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.
Time frame: 6 months
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Light Adjustable Lens Implanted | Uncorrected Visual Acuity 20/20 or Better | 70.1 percentage of eyes |
| Control IOL Implanted | Uncorrected Visual Acuity 20/20 or Better | 36.3 percentage of eyes |
p-value: <0.0001Chi-squared