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| General |
| Study Status |
Ongoing |
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)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| 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?
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| 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.
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| 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.
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| 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
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| Follow-up Visits and Length of Follow-up |
6 months minimum, except in cases where UV retinal damage is confirmed then 12 months minimum.
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