Aphakia, Cataract
Conditions
Keywords
Light Delivery Device, LDD, Intraocular lens, Light Adjustable Lens, LAL
Brief summary
The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.
Interventions
DEVICELight Delivery Device (LDD)
Study eye will undergo 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
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments * A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment. * Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder. * Between the ages of 40 and 80 inclusive on the day the informed consent form is signed. * Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better. * Willing and able to comply with the requirements for study specific procedures and visits
Exclusion criteria
* Pre-existing macular disease in the study eye. * History of uveitis in the study eye. * Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and 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. * Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * History of ocular herpes simplex virus in the study eye. * Subject who has participated within another ophthalmic clinical trial within the last 3 months. * Sutures used at the time of surgery to close the incision wound in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | Post Op Month 3 |
| Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | Post Op Month 3 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated) | Through study completion, an average of 3 months | Number of study eyes experiencing Ocular adverse events (device related and unrelated) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Light Delivery Device (LDD) Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.
Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Light Delivery Device (LDD) |
|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 5.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 4 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time frame: Post Op Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Delivery Device (LDD) | Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | 0.36 Diopter (D) | Standard Deviation 0.21 |
Comparison: Two different historical controls implanted under NCT01496066 were used.
Primary
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time frame: Post Op Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Delivery Device (LDD) | Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | -0.14 Diopter (D) | Standard Deviation 0.21 |
Comparison: Two different historical controls implanted under NCT01496066 were used.
Other Pre-specified
Safety: ISO 11979-7 Number of Eyes With 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 3 months
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Light Delivery Device (LDD) | Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated) | 4 eyes |