Aphakia, Cataract
Conditions
Keywords
Light Adjustable Lens, Intraocular lens, LAL
Brief summary
The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.
Interventions
Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
Sponsors
RxSight, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.
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 unilateral or bilateral implantation of the RxLAL. * Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. * Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D. * Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source. * Willing and able to comply with the requirements for study specific procedures and visits.
Exclusion criteria
* Study eye with zonular laxity or dehiscence. * Study eye with pseudoexfoliation. * Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen. * Study eye with diabetes with any evidence of retinopathy. * Study eye with evidence of glaucomatous optic neuropathy. * Study eye with history of uveitis. * Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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. * Study eye with history of ocular herpes simplex virus. * Study eye with history of a congenital color vision defect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Eyes With UCDVA of 20/20 or Better | 6 months |
Countries
Mexico
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): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments | 21 |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments | 42 |
| Total | 63 |
Baseline characteristics
| Characteristic | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Mexico | 21 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 1 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Percent of Eyes With UCDVA of 20/20 or Better
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Percent of Eyes With UCDVA of 20/20 or Better | 41 Eyes |