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
30 Years to No maximum
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. * Age 30 or older 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 zonular laxity or dehiscence. * Study eye with diabetes with any evidence of retinopathy. * Study eye with history of uveitis. * 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. * Study eye with history of ocular herpes simplex virus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | 3 months post op | Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing. |
| Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better | 12 months post op | Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment |
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 | 79 |
| Total | 79 |
Baseline characteristics
| Characteristic | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 7.2 |
| Race/Ethnicity, Customized Black | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 20 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 59 Participants |
| Region of Enrollment Mexico | 79 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 79 |
| other Total, other adverse events | 9 / 79 |
| serious Total, serious adverse events | 2 / 79 |
Outcome results
Primary
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
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 | 21 Eyes |
Primary
Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better
Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment
Time frame: 12 months post op
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better | 91 Eyes |