Cataract
Conditions
Keywords
cataract surgery, eye disease, lenticular opacification
Brief summary
For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.
Interventions
DEVICERxSight RxLAL
The patients will be assessed for 6 months
Sponsors
RxSight, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of the RxLAL. * Greater than the age of 40 on the day the cataract surgery is performed. * Preoperative keratometric cylinder of \>=0.50 D and \<=4.00 D in both eyes. * Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes. * Willing and able to comply with the requirements for study specific procedures and visits.
Exclusion criteria
* Zonular laxity or dehiscence. * Age-related macular degeneration involving the presence of geographic atrophy or soft drusen. * Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss. * History of uveitis * Keratoconus or suspected of having keratoconus. * Previous corneal or intraocular surgery, 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. * Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject. * Subjects taking systemic medications 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 * History of congenital color vision defect
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | at 6 months postop | Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated) | Through study completion, an average of 6 months | Number of study eyes experiencing Ocular adverse events (device related and unrelated) |
| Number of Eyes That Received Secondary Surgical Interventions (SSIs) | Through study completion, an average of 6 months | Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study. |
Countries
Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RxSight RxLAL IOL Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)
RxSight RxLAL: The patients will be assessed for 6 months | 51 |
| RxSight RxLAL IOL Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)
RxSight RxLAL: The patients will be assessed for 6 months | 101 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen failure | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | RxSight RxLAL IOL |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 9.7 |
| Fellow Eyes Enrolled OD | 24 Eyes |
| Fellow Eyes Enrolled OS | 26 Eyes |
| Primary Eyes Enrolled OD | 26 Eyes |
| Primary Eyes Enrolled OS | 25 Eyes |
| Race/Ethnicity, Customized Asian | 0 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants |
| Race/Ethnicity, Customized White | 51 participants |
| Region of Enrollment Germany | 43 participants |
| Region of Enrollment United Kingdom | 8 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 28 / 101 |
| serious Total, serious adverse events | 2 / 101 |
Outcome results
Primary
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
Time frame: at 6 months postop
Population: A modified Effectiveness (m-Effectiveness) population was used for all effectiveness analyses which includes all observed data without treatment related protocol deviations.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| RxSight RxLAL IOL | Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | 45 Eyes |
Other Pre-specified
Number of Eyes That Received Secondary Surgical Interventions (SSIs)
Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.
Time frame: Through study completion, an average of 6 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| RxSight RxLAL IOL | Number of Eyes That Received Secondary Surgical Interventions (SSIs) | 1 Eyes |
Other Pre-specified
Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)
Number of study eyes experiencing Ocular adverse events (device related and unrelated)
Time frame: Through study completion, an average of 6 months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| RxSight RxLAL IOL | Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated) | 3 Eyes |