Aphakia, Cataract, Presbyopia
Conditions
Keywords
Light Adjustable Lens, Intraocular lens, LAL
Brief summary
The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).
Interventions
DEVICELight Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
DEVICESofPort LI61AO IOL
Control treatment group will receive SofPort LI61AO IOL
DEVICETecnis ZCB00 or ZTC150 IOL
Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL
Sponsors
RxSight, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Select post operative assessments will be performed on both the experimental and control treatment groups by an examiner who will be masked to the treatment group assignments.
Intervention model description
Subjects will be randomized 1:1 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 bilateral implantation of either the LAL or SofPort LI61AO intraocular lens (IOL) (Bausch + Lomb). * Must be willing to be randomized to either the LAL group (bilaterally implanted with the LAL and receive light treatments for refractive and presbyopia correction) or the Control group * Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. * Cataractous lens changes as demonstrated by best corrected distance visual acuity (BCDVA) of 20/40 or worse with or without a glare source in both eyes. * 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. * Patient with sufficiently dense cataract that precludes examination of the macula in either eye. * Diabetes with any evidence of retinopathy in either eye. * Evidence of glaucomatous optic neuropathy in either eye. * History of uveitis in either eye. * Keratoconus or suspected of having keratoconus in either eye. * Has undergone previous corneal or intraocular surgery in either eye, except 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 such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation. * Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * History of ocular herpes simplex virus in either eye. * Subject who has participated within another ophthalmic clinical trial within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group | Postop Month 6 | Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group. |
| Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group | Postop Month 6 | Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups |
| Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6 | 6 months | Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR |
| Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group | Postop Month 6 | Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments | 10 |
| Tecnis ZCB00 or ZTC150 IOL Tecnis ZCB00/ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL | 7 |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments | 7 |
| SofPort LI61AO IOL SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL | 10 |
| Total | 34 |
Baseline characteristics
| Characteristic | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Total | SofPort LI61AO IOL | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population | Tecnis ZCB00 or ZTC150 IOL |
|---|---|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 8.7 | 66.4 years STANDARD_DEVIATION 7.3 | 66.6 years STANDARD_DEVIATION 5.5 | 65.4 years STANDARD_DEVIATION 8.5 | 69.2 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 27 Participants | 10 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black/African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Caucasian | 9 Participants | 33 Participants | 10 Participants | 7 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 23 Participants | 7 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 11 Participants | 3 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 | 0 / 7 | 0 / 10 |
| other Total, other adverse events | 9 / 10 | 2 / 7 | 4 / 7 | 1 / 10 |
| serious Total, serious adverse events | 1 / 10 | 1 / 7 | 1 / 7 | 1 / 10 |
Outcome results
Primary
Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group
Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group.
Time frame: Postop Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group | 2.30 Diopters |
| Tecnis ZCB00 or ZTC150 IOL | Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group | 0.97 Diopters |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population | Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group | 1.58 Diopters |
| SofPort LI61AO IOL | Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group | 0.85 Diopters |
Primary
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group
Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups
Time frame: Postop Month 6
Population: Since the sample sizes of each group did not meet the minimum requirements (42 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group | 0.00 LogMAR |
| Tecnis ZCB00 or ZTC150 IOL | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group | -0.11 LogMAR |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group | 0.02 LogMAR |
| SofPort LI61AO IOL | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group | -0.06 LogMAR |
Primary
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group
Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups
Time frame: Postop Month 6
Population: Since the sample sizes of each group did not meet the minimum requirements (8 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group | 0.09 LogMAR |
| Tecnis ZCB00 or ZTC150 IOL | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group | 0.29 LogMAR |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group | 0.13 LogMAR |
| SofPort LI61AO IOL | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group | 0.33 LogMAR |
Primary
Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6
Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR
Time frame: 6 months
Population: Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled (Light adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID population and TECNIS ZCB00 or ZTC150 IOL) may have been delayed outside protocol specified windows or missed completely. Since the sample sizes of each group did not meet the minimum requirements (28 eyes per lens group) for statistical power per study protocol, 95% confidence intervals were calculated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6 | 80 percentage of Primary Eyes |
| Tecnis ZCB00 or ZTC150 IOL | Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6 | 71.4 percentage of Primary Eyes |