|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160055 / PAS001 |
| Date Original Protocol Accepted |
03/04/2019
|
| Date Current Protocol Accepted |
02/16/2023
|
| Study Name |
LAL/LDD Postmarket RCT
|
| Device Name |
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
|
| Clinical Trial Number(s) |
NCT00845520 NCT01496066
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A two-phased study (Phase A and B) will be conducted that evaluate the following two safety questions: (1) What is the rate of endothelial cell density loss (ECL) for patients with the RxSight LAL/LDD? (2) What is the rate of retinal damage caused by UV treatment with the LDD that may not be detected by routine post-operative testing?
|
| Study Population |
• Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight
LAL or the monofocal control IOL.
• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
• Preoperative corneal cylinder greater than or equal to 0.75 diopters (D) to less than or equal to 2.00 D or >2.00 D and < 2.5 D
of corneal cylinder with a steep axis between 70 degrees and 110 degrees.
• Study eye has best corrected distance visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/20 or better after cataract removal and IOL implantation.
• Study eye has clear intraocular media other than cataract.
• Willing and able to comply with the requirements for study specific procedures and visits.
• Study eye has average dilated pupil diameter of greater than or equal to 7.0 mm.
• Able to complete a written questionnaire in English.
• Study eye requires an IOL power within the range available for the RxSight LAL.
|
| Sample Size |
Phase A – 24 English speaking patients in the EU at 1-3 sites
Phase B – 500 subjects at 10 sites randomized 2:1 to receive either a RxSight LAL (333 eyes) or monofocal control (167 eyes). Only one eye per subject may be included in the study. Calculation is based on the two primary safety endpoints described below.
|
| Key Study Endpoints |
The primary effectiveness endpoints are:
Mean absolute manifest refraction spherical equivalent (|MRSE|) at postop month 6 compared between the RxSight LAL and Control group
Mean manifest cylinder at postop month 6 compared between the RxSight LAL and Control group
The primary safety endpoints are:
Mean rate of endothelial cell density loss at postop month 6 compared to preoperatively compared between the RxSight LAL and Control group
Percent of RxSight LAL eyes with UV retinal damage at postop month 6
|
| Follow-up Visits and Length of Follow-up |
6 months minimum, except in cases where UV retinal damage is confirmed then 12 months minimum.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
592 enrolled and 500 eyes implanted with the LAL or control IOL.
|
| Actual Number of Sites Enrolled |
15 sites
|
| Patient Follow-up Rate |
All LAL eyes were seen at all required visits that they were eligible for through Lock-in #2. At Months 1-2, 1 eye (0.3%) was lost to follow-up leading to 99.7% (334/335) accountability. At Month 6, 3 eyes (0.9%) were lost to follow-up resulting in 99.1% (332/335) accountability for the LAL group.
In the Control group, 1 eye (0.6%) missed the Day 1 visit. All Control eyes were seen at the Week 1 and Week 3 exams. At Months 1-2, one eye (0.6%) was lost to follow-up leading to 99.4% (164/165) accountability. At Month 6, accountability remained at 99.4% (164/165) accountability.
Accountability throughout the study exceeded 99% at all times.
|
| Final Safety Findings |
Both co-primary safety endpoints were met.
For the first co-primary safety endpoint, the median rate of endothelial cell loss (ECL) at Month 6 was 5.1% in the LAL group and 4.9% in the Control group compared to preoperative. The median observed difference was 0.2% (90% Hodges-Lehmann confidence interval: -1.00%, 1.66%). The median difference was compared against a 5% noninferiority margin for ECL using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05. This comparison showed that the LAL group was not inferior to the Control group (p-value <0.0001), indicating the first co-primary safety endpoint was met.
For the second co-primary safety endpoint, no LAL eyes (0/331) were diagnosed with UV retinal damage at Month 6 or at any other time during the study.
|
| Final Effect Findings |
Both co-primary effectiveness endpoints were met.
Analysis of the first co-primary effectiveness endpoint showed the mean |MRSE| at Month 6 was +0.210 ± 0.213 D in the LAL group compared to +0.345 ± 0.265 D in the Control group, representing a smaller residual refractive error for the LAL group compared with the Control group at Month 6.
For the second co-primary effectiveness endpoint, the mean manifest refraction cylinder (MRCYL) at Month 6 was 0.262 ± 0.275 D in the LAL group compared to 0.820 ± 0.554 D in the Control group. The median MRCYL was 0.25 D in the LAL group compared to 0.75 D in the Control group. Additionally, at Month 6, 92.5% of LAL eyes had an MRCYL of 0.50 D or less compared to 37.2% for the Control group. MRCYL > 1.00 D was present in only 1.2% of LAL eyes compared to 28.1% of Control eyes.
|
| Study Strengths & Weaknesses |
n/a
|
| Recommendations for Labeling Changes |
yes
|
