Aphakia, Cataract
Conditions
Keywords
Light Adjustable Lens, Intraocular lens, LAL
Brief summary
The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.
Interventions
Eligible 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
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 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 pseudoexfoliation. * 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 Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | 3 months post op |
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): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments | 66 |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments | 111 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 7.2 |
| Eyes OD | 56 Eyes |
| Eyes OS | 55 Eyes |
| Race/Ethnicity, Customized Black | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 66 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants |
| Region of Enrollment Mexico | 66 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 66 |
| other Total, other adverse events | 25 / 111 |
| serious Total, serious adverse events | 0 / 111 |
Outcome results
Primary
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Time frame: 3 months post op
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | 101 Eyes |