Aphakia, Cataract
Conditions
Keywords
Light Adjustable Lens, LAL, Intraocular lens
Brief summary
The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.
Interventions
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
DEVICEControl IOL
Control treatment group will receive a Control IOL
Sponsors
RxSight, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Subjects will be randomized 2:1 to undergo experimental or control treatment.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL. * Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. * Willing and able to comply with the requirements for study specific procedures and visits. * Able to complete a written questionnaire in English.
Exclusion criteria
* Pre-existing macular disease in either eye. * Patients with sufficiently dense cataracts that preclude examination of the macula in either eye. * History of uveitis in either eye. * Evidence of ectasia in either eye. * Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus. * Subjects taking systemic medication that may increase sensitivity to UV light. * Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * History of ocular herpes simplex virus in either eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 |
| Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Endothelial Cell Density Loss | Postop Month 6 | The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05. |
| Rate of Retinal Findings | Postop Month 6 | Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments | 335 |
| Control IOL Control IOL: Control treatment group will receive a Control IOL | 165 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Control IOL | Total | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 6.3 | 67.1 years STANDARD_DEVIATION 6.8 | 67.3 years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 31 Participants | 23 Participants |
| Race/Ethnicity, Customized Caucasian | 156 Participants | 461 Participants | 305 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 165 participants | 500 participants | 335 participants |
| Sex: Female, Male Female | 106 Participants | 333 Participants | 227 Participants |
| Sex: Female, Male Male | 59 Participants | 167 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 335 | 0 / 165 |
| other Total, other adverse events | 71 / 335 | 26 / 165 |
| serious Total, serious adverse events | 7 / 335 | 2 / 165 |
Outcome results
Primary
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | 0.262 Diopters | Standard Deviation 0.275 |
| Control IOL | Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | 0.820 Diopters | Standard Deviation 0.554 |
Primary
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | 0.210 Diopters | Standard Deviation 0.213 |
| Control IOL | Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | 0.345 Diopters | Standard Deviation 0.265 |
Secondary
Rate of Endothelial Cell Density Loss
The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.
Time frame: Postop Month 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Rate of Endothelial Cell Density Loss | 5.1 percentage Endothelial Cell Change |
| Control IOL | Rate of Endothelial Cell Density Loss | 4.9 percentage Endothelial Cell Change |
Comparison: With a one-sided significance level of 0.05, a power of 0.80, a randomization ratio of 2:1, and then the Mann-Whitney-Wilcoxon asymptotic relative efficiency (A.R.E.) efficiency adjustment, the sample size per two-sample t-test is 192 LAL eyes and 96 Control eyes (total of 288), with an assumed dropout rate of 10%.p-value: <0.000190% CI: [-1, 1.66]Wilcoxon (Mann-Whitney)
Secondary
Rate of Retinal Findings
Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.
Time frame: Postop Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Rate of Retinal Findings | 0 Participants |
Post Hoc
Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group | Absolute MRCYL 0.50 D or less | 307 Participants |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group | Absolute MCRYL worse than 0.50 D | 25 Participants |
| Control IOL | Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group | Absolute MRCYL 0.50 D or less | 61 Participants |
| Control IOL | Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group | Absolute MCRYL worse than 0.50 D | 103 Participants |
95% CI: [12.05, 36.14]
Post Hoc
Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group | Simultaneous absolute MRSE and absolute MRCYL of 0.50 D or less | 291 Participants |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group | Simultaneous absolute MRSE and absolute MRCYL worse than 0.50 D | 41 Participants |
| Control IOL | Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group | Simultaneous absolute MRSE and absolute MRCYL of 0.50 D or less | 54 Participants |
| Control IOL | Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group | Simultaneous absolute MRSE and absolute MRCYL worse than 0.50 D | 110 Participants |
95% CI: [8.89, 23.57]
Post Hoc
Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group
Success defined as UCDVA 20/20 or better, failure defined as UCDVA worse than 20/20. Odds defined as number of successes divided by number of failures.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group | UCDVA 20/20 or better | 274 Participants |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group | UCDVA worse than 20/20 | 58 Participants |
| Control IOL | Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group | UCDVA 20/20 or better | 83 Participants |
| Control IOL | Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group | UCDVA worse than 20/20 | 81 Participants |
95% CI: [2.97, 7.15]