A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
Phase: NA
Conditions: Cataract, Corneal Astigmatism, Aphakia
Sponsor: ClarVista Medical

Short Title 
ClarVista CP-00002 / NCT03054649
Long Title 
A 
PROSPECTIVE, MULTI-CENTER STUDY 
TO EVALUATE THE 
SAFETY 
AND PERFORMANCE OF 
THE 
EXCHANGEABLE CLARVISTA HARMONI™ MODULAR TORIC 
INTRAOCULAR LENS SYSTEM FOR THE 
TREATMENT OF PRE-EXISTING CORNEAL 
ASTIGMATISM AND 
APHAKIA 
FOLLOWING CATARACT 
SURGERY 
1 
TITLE PAGE 
Protocol Number:  
ClarVista CP-00002 
Medical Specialty: 
Surgical 
Project Name /Number:  
NA 
Sponsor Name & Address: 
CLARVISTA
 MEDICAL, INCORPORATED 
26800 ALISO VIEJO PARKWAY
, SUITE 120 
ALISO VIEJO, CA
 92656 
PHONE +001 949 916-5412 
FAX +001 949 916-5412 
Test Article(s) / Product(s):  
ClarVista HARMONI®
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 Modular Toric Intraocular Lens 
System

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PROTOCOL 
ROTOCOL # CP-00002
CP-00002 REV
EV.03 
 
C
.03 
 
CLAR
LARVISTA 
ISTA MEDICAL
EDICAL 
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Abbreviation/Acronym   Term  
™
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–
 
two MR evaluations at least 1 week apart resulting in ≤0.50D MRSE 
ast 1 week apart resulting in ≤0.50D 
 
 
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neal, Fuch’s, or anterior membrane dystrophies, etc.) in 
 
 
 
 
 
 
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–
 
 
 
 
 
 
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IOL exchange/manipulation, or sulcus placement of a “piggyback” IOL
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Sulcus placement of a “piggyback” 
result without the need to implant a “piggyback” IOL with its inherent serious risks.
ipulation of traditional IOL’s 
 
–
full lens exchange or resorting to the use of a corneal refractive laser.  With the HARMONI™ design the 
 
–
urgical intervention (SSI) in the form of IOL repositioning to resolve  RRE.  
  The  HARMONI™ 
HARMONI™
HARMONI™ Modular 
 
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–
 
 
 
 
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–
 
resulting in ≤0.50D MRSE difference in the two refractions) and Keratometry readings (as 
K readings at least 1 week apart resulting in ≤0.50D difference between the two readings) prior to final IOL 
 
 
 
 
 
 
 
 
 
 
 
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corneal, Fuch’s, or anterior membrane dystrophies, etc.) in either eye
 
 
 
 
 
 
 
–
 
 
 
 
 
 
 
frequency of each assessment to be performed at each visit, will be carried out according to “Appendix 
–Schedule of Assessments.”  
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and both remain “inwindow,” the subject must return for a separate visit in order to maintain “inwindow” status for 
–
 
 
 
 
 
 
 
 
 
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–
–
 
 
 
 
 
 
 
 
 
–
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d “missed”
d for by the Sponsor to the extent it is not covered by a subject’s 
’s signature
’s medical chart.  
subject’s 
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capsular rupture, vitreous loss, posterior capsular plaque, significant detached Descemet’s membrane, significant 
 
subjects  should  be  followed  outside  of  the  study  protocol  according  to  the  Investigator’s  normal  postoperative 
up  attempts  will  be  documented  and  kept  with  the  subject’s  source 
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This will be listed as “Nd:YAG Capsulotomy.”
–
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subject’s condition requires that he/she be discontinued from the study.
™
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 “For Single Use Only” statement (or equivalent symbol)
 
 Storage temperature range requirements or equivalent (e.g. “Store at room temperature.”)
 
 
 
 
 
 
 
 
 
 
 
 
Investigator’s accountability records. Following verification, and as directed by the Sponsor, all unused and explanted 
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–
 
 
 
 
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interfere with the subject’s daily activities
 
 
tom that interrupts the subject’s
 daily activity and requires systemic therapy or 
 
 
 
 
 
 
 
 
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Investigators may receive “offsite” reports (e
per the Investigator’s standa
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subject’s 
revised as necessary to ensure subjects’ consent to continue participation given the known revised risks.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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HMIOL’s effect on
 
 
 
 
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–
–
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–
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shipped (at Sponsor’s expense) for archival purposes, as an alternative to disposal.
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