A Multi-center, Prospective Clinical Trial to Evaluate the Safety and Effectiveness of a Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal
Phase: NA
Conditions: Cataract Unilateral, Aphakia
Sponsor: Estelle Poineau

 
Carl Zeiss Meditec Production, LLC  
 Study Protocol 611P ONT-301-17, VERSION E 
 
 
21-DEC-2018 
 
CONFIDENTIAL –PAGE 9 OF 56 
 
NDC# 7425 
A MULTI-CENTER, PROSPECTIVE CLINICAL TRIAL TO EVALUATE THE SAFETY AND 
EFFECTIVENESS OF THE CT LUCIA 611P POSTERIOR CHAMBER  
INTRAOCULAR LENS FOR CORRECTION OF APHAKIA  
FOLLOWING CATARACT REMOVAL  
(IDE 611 STUDY) 
PROTOCOL # CT LUCIA 611P ONT-301-17, VERSION E 
 
STUDY SYNOPSIS 
 
1. Study Objective 
 
To establish the safety and effectiveness of the CT LUCIA 611P posterior chamber intraocular lens (IOL) 
for the correction of aphakia following extracapsular cataract extraction via phacoemulsification in adult 
patients.  
 
2. Study Device 
 
The CT LUCIA 611P is a posterior chamber hydrophobic acrylic IOL, which is designed for implantation 
in the capsular bag following cataract extraction, contained in a BLUEJECT injector.  The IOL is a single-
piece design with 6.0 mm optic diameter and 13.0 mm overall diameter.  The optic of the CT LUCIA 611P 
is monofocal biconvex aspheric in design, with edges designed to minimize mass; the lens haptics are 
modified C-loop with 0° angulation. 
 
3. Study Endpoints  
 
• 
Effectiveness:  The primary effectiveness endpoint is the proportion of subject
 
 
 
• 
Safety: The primary safety endpoints are the incidence of adverse events (AE).   
 
4. Study Design 
  
 
 
 
This is a prospective, multi-center single-arm clinical study.  Subjects will be enrolled at approximately 15 
investigational sites located in the U.S.  Only 1 eye per subject may receive the study device.  All subjects 
who undergo surgery and study device implantation will be followed for 12 months post-surgery. 
 
5. Subject Population 
 
 
Adult subjects undergoing extracapsular cataract extraction via phacoemulsification followed by 
implantation of a posterior chamber IOL.   
 
6. Number of Eyes 
 
390 eyes enrolled, with ≥ 300 eyes followed through 12 months postoperatively.   

 
Carl Zeiss Meditec Production, LLC  
 Study Protocol 611P ONT-301-17, VERSION E 
 
 
21-DEC-2018 
 
CONFIDENTIAL –PAGE 10 OF 56 
 
NDC# 7425 
7. Study Treatment  
 
Candidate patients will be screened to determine study eligibility, then examined to obtain their medical 
and ophthalmic history and establish baseline ocular condition. Qualified subjects will undergo 
extracapsular cataract extraction via phacoemulsification followed by implantation with the 
CT LUCIA 611P IOL in the study eye.  Postoperatively, subjects will undergo protocol-specified 
ophthalmic examinations at regularly scheduled intervals. 
 
8. Examination Schedule 
 
Scheduled examinations will be performed at the intervals shown below:    
 
 
• 
Pre-operative Visit (-90 - 0 days) 
• 
Operative Visit (Day 0) 
 
 
 
• 
1 Day Postoperative Visit (1 - 2 days post-surgery)  
• 
1 Week Postoperative Visit (7 - 14 days post-surgery)                   
• 
1 Month Postoperative Visit (30 - 60 days post-surgery) 
 
• 
6 Months Postoperative Visit (120 - 180 days post-surgery) 
• 
12 Months Postoperative Visit (330 - 420 days post-surgery)  
 
Note:  Unscheduled visits may occur at any time during the study participation period. 
 
 
 
 
 
9. Clinical Assessments/Procedures  
 
 
The following clinical assessments will be performed at scheduled examination visits as shown in 
APPENDIX 1:  SCHEDULE OF CLINICAL ASSESSMENTS/PROCEDURES: 
 
• 
Medical and ophthalmic history 
• 
Concomitant medication use 
• 
Study eye axial length (AL), anterior chamber depth (ACD) and keratometry (K) measurement 
• 
Study eye cataract removal and IOL implantation information 
• 
Uncorrected and best-corrected distance VA 
• 
Manifest refraction (MR) 
• 
Slit lamp examination (SLE) 
• 
Dilated fundus examination (DFE) 
• 
Intraocular pressure (IOP) measurement 
• 
Adverse event (AE) determination 
 
Note:  Clinical assessments/procedures performed at unscheduled examination visits will be determined at 
the study investigator’s discretion. 
 
 

 
Carl Zeiss Meditec Production, LLC  
 Study Protocol 611P ONT-301-17, VERSION E 
 
 
21-DEC-2018 
 
CONFIDENTIAL –PAGE 11 OF 56 
 
NDC# 7425 
10. Study Duration 
              
 
The duration of each subject’s study participation is nominally estimated to be approximately 13 months; 
however, duration of participation is affected by the time lapse between the Preoperative Visit, which 
may occur between Day -90 and Day 0, and the Operative Visit on Day 0.  Each subject will be followed 
for 12 months after the Operative Visit.  Of note, the 12-Month Visit may occur at any time between 11 
and 14 months postoperatively.   
 
The total anticipated duration of this clinical investigation is approximately 21 – 26 months.