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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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LAL/LDD Postmarket RCT


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General
Study Status Progress Adequate
Application Number P160055 / PAS001
Date Current Protocol Accepted  
Study Name LAL/LDD Postmarket RCT
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A two-phased new enrollment study, Phase A and Phase 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?

The primary objective of Phase A is to develop a patient-reported outcome (PRO) instrument that will assess erythropsia after LDD light treatments, the “Daily Life Erythropsia Questionnaire” (DLEQ). Phase A is a non-interventional, cross-sectional, cognitive debriefing interview study at 1-3 sites with 24 English speaking patients who have undergone cataract surgery with implantation of the RxSight LAL and had treatment performed with the Light Delivery Device.



Phase B is a prospective, randomized, controlled, multicenter study that will be conducted at up to 10 clinical sites with 500 patients who will be followed up to 12 months post-operatively and will be randomized 2:1 to receive either an RxSight LAL or a monofocal control IOL. Phase B will begin after the developed of the DLEQ PRO is complete and has been accepted by FDA, and is expected to last up to 30 months and include up to 12 study visits.



Study Population Description Inclusion Criteria:

Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.

Preoperative corneal cylinder =0.75 D to =2.00 D or >2.00 diopters and = 2.5 diopters 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 = 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.

Data Collection 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 comparisons will be made by descriptive statistics only.



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



UV retinal damage will be diagnosed if the SD-OCT scan demonstrates disruption of the inner/outer segment junction, the outer nuclear layer, or retinal pigment epithelial layer. SDOCT was selected for diagnosis of UV retinal damage as it is the most sensitive diagnostic imaging technique as a complement to other assessments.1



Other Key Safety parameters are:



Rates of erythropsia at each visit beginning at Postop Week 3, as evaluated by the in-office erythropsia assessment, in RxSight LAL eyes



Rates of erythropsia at each visit beginning at Postop Week 3, as evaluated by the Daily Life Erythropsia Questionnaire (DLEQ), in RxSight LAL eyes



Rates of tritan anomaly on the City University Color Test at each visit beginning at Postop Week 3, in RxSight LAL eyes



Rates of all types of adverse events, including loss of best corrected distance visual acuity (BCDVA) of =2 lines from Postop Week 3 visit, in RxSight LAL eyes



In specular microscopy sub-study compared between the RxSight LAL and Control group:



Rate of within-eye loss of =25% ECD from preoperative visit at Postop Week 3 and Postop Month 6



Rate of within-eye loss of =30% ECD from preoperative visit at Postop Week 3 and Postop Month 6



Rates of findings on SWAP testing consistent with ultraviolet retinal damage per an independent expert



Rates of findings on ERG testing consistent with ultraviolet retinal damage per an independent expert



Follow-up Visits and Length of Follow-up 6 months minimum, except in cases where UV retinal damage is confirmed then 12 months minimum.


LAL/LDD Postmarket RCT Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/23/2018 06/19/2018 Overdue/Received
one year report 09/04/2019 08/28/2019 On Time
18 month report 03/04/2020    
two year report 09/04/2020    
three year report 09/04/2021    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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