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Clinical Investigation of the Next-Generation Intraocular Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372434
Recruitment Status : Completed
First Posted : December 13, 2017
Results First Posted : July 27, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: Investigational Intraocular Lens Device #1: Model ZFR00
Device: Investigational Intraocular Lens Device #1: Model ZYR00
Device: TECNIS Multifocal Intraocular Lens: Model ZLB00
Enrollment 225
Recruitment Details  
Pre-assignment Details 225 subjects were implanted with a study lens in at least one eye. Two hundred and twenty five (225) subjects had a study IOL in the first eye.
Arm/Group Title Model ZFR00 Model ZLB00 Model ZYR00
Hide Arm/Group Description Investigational IOL implanted in the first eye Control IOL implanted in the first eye Investigational IOL implanted in the first eye
Period Title: Overall Study
Number of participants Number of units (Eyes) Number of participants Number of units (Eyes) Number of participants Number of units (Eyes)
Started [1] 78 78 73 73 74 74
1 Month Follow-up 76 76 72 72 73 73
Completed [2] 76 76 70 70 72 72
Not Completed 2 2 3 3 2 2
[1]
Implanted with a study lens in at least one eye
[2]
6 months follow up
Arm/Group Title Model ZFR00 Model ZLB00 Model ZYR00 Total
Hide Arm/Group Description Investigational IOL implanted in the first eye Control IOL implanted in the first eye Investigational IOL implanted in the first eye Total of all reporting groups
Overall Number of Baseline Participants 78 73 74 225
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 78 participants 73 participants 74 participants 225 participants
Less than <60 years 10 13 17 40
60-69 years 38 35 34 107
70-79 years 27 23 21 71
Greater than or equal to >/80 years 3 2 2 7
Not reported 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 73 participants 74 participants 225 participants
Female
54
  69.2%
48
  65.8%
49
  66.2%
151
  67.1%
Male
24
  30.8%
25
  34.2%
25
  33.8%
74
  32.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 73 participants 74 participants 225 participants
Hispanic or Latino
4
   5.1%
6
   8.2%
3
   4.1%
13
   5.8%
Not Hispanic or Latino
74
  94.9%
67
  91.8%
71
  95.9%
212
  94.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 78 participants 73 participants 74 participants 225 participants
Asian (including Indian) 0 3 0 3
Black 3 7 7 17
Native Hawaiian/Pacific Islander 0 0 0 0
Caucasian 75 62 66 203
Another Race 0 1 0 1
Not reported 0 0 1 1
1.Primary Outcome
Title Distance Corrected Intermediate Visual Acuity
Hide Description Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Model ZFR00 Model ZLB00 Model ZYR00
Hide Arm/Group Description:
Investigational IOL implanted in the first eye
Control IOL implanted in the first eye
Investigational IOL implanted in the first eye
Overall Number of Participants Analyzed 76 72 73
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 76 72 73
Mean (Standard Deviation)
Unit of Measure: LogMAR
0.098  (0.115) 0.219  (0.146) 0.147  (0.149)
Time Frame 6 months
Adverse Event Reporting Description All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
 
Arm/Group Title Model ZFR00 Model ZLB00 Model ZYR00
Hide Arm/Group Description Investigational IOL device Control IOL Device Investigational IOL Device
All-Cause Mortality
Model ZFR00 Model ZLB00 Model ZYR00
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)      0/73 (0.00%)      0/74 (0.00%)    
Hide Serious Adverse Events
Model ZFR00 Model ZLB00 Model ZYR00
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/78 (6.41%)      13/73 (17.81%)      4/74 (5.41%)    
Blood and lymphatic system disorders       
B-cell Lymphoma †  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Cardiac disorders       
Patent Foramen Ovale †  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Angioplasty *  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Eye disorders       
Cystoid Macular Edema *  0/78 (0.00%)  0 0/73 (0.00%)  0 2/74 (2.70%)  2
Macular Hole †  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Herpes Zoster Keratitis *  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Retinal Detachment †  1/78 (1.28%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Haptic anterior to capsule bag *  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Increase in cells likely due to non-compliance with ocular medication regimen *  1/78 (1.28%)  1 0/73 (0.00%)  0 0/74 (0.00%)  0
Retinal Hole †  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
General disorders       
Hospitalization *  0/78 (0.00%)  0 3/73 (4.11%)  3 1/74 (1.35%)  1
Undisclosed illness requiring Hospice care *  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Infections and infestations       
Shingles * [1]  0/78 (0.00%)  0 1/73 (1.37%)  1 0/74 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer †  1/78 (1.28%)  1 1/73 (1.37%)  1 0/74 (0.00%)  0
Product Issues       
Bothersome Visual Symptom * [2]  1/78 (1.28%)  1 1/73 (1.37%)  1 1/74 (1.35%)  1
Visual symptoms requiring secondary surgical intervention *  1/78 (1.28%)  1 0/73 (0.00%)  0 1/74 (1.35%)  1
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
with permanent nerve damage
[2]
Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Model ZFR00 Model ZLB00 Model ZYR00
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/78 (7.69%)      1/73 (1.37%)      3/74 (4.05%)    
Product Issues       
Bothersome visual symptom * [1]  6/78 (7.69%)  6 1/73 (1.37%)  1 3/74 (4.05%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eugenia Thomas, OD
Organization: Johnson & Johnson Surgical Vision
Phone: +1 657 2903260
EMail: EThoma39@its.jnj.com
Layout table for additonal information
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT03372434    
Other Study ID Numbers: SUR-CAT-652-1001
First Submitted: December 8, 2017
First Posted: December 13, 2017
Results First Submitted: May 19, 2021
Results First Posted: July 27, 2021
Last Update Posted: July 27, 2021