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Clinical Investigation of a New Intraocular Lens

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ClinicalTrials.gov Identifier: NCT02203721
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Device: TECNIS Monofocal IOL, Model ZCB00
Enrollment 324
Recruitment Details Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.
Pre-assignment Details A total of 23 subjects were consented but were not assigned to a group due to failure to meet inclusion/exclusion criteria, withdrawn consent, non-ocular health, or lost-to-follow-up.
Arm/Group Title TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00
Hide Arm/Group Description Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Period Title: Overall Study
Started 148 151
Completed 147 148
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             0
Death             0             2
Illness             0             1
Arm/Group Title TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00 Total
Hide Arm/Group Description Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00 Total of all reporting groups
Overall Number of Baseline Participants 148 151 299
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 151 participants 299 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
85
  57.4%
85
  56.3%
170
  56.9%
>=65 years
63
  42.6%
66
  43.7%
129
  43.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 151 participants 299 participants
68.0  (7.5) 67.9  (7.9) 67.9  (7.7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 151 participants 299 participants
Female
91
  61.5%
86
  57.0%
177
  59.2%
Male
57
  38.5%
65
  43.0%
122
  40.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 148 participants 151 participants 299 participants
148 151 299
1.Primary Outcome
Title Distance Corrected Intermediate Visual Acuity
Hide Description FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00
Hide Arm/Group Description:
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Overall Number of Participants Analyzed 147 148
Mean (Standard Error)
Unit of Measure: LogMAR
0.105  (0.009) 0.343  (0.013)
2.Primary Outcome
Title Uncorrected Intermediate Visual Acuity
Hide Description Uncorrected Intermediate Visual Acuity at 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population
Arm/Group Title TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00
Hide Arm/Group Description:
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Overall Number of Participants Analyzed 147 148
Mean (Standard Error)
Unit of Measure: LogMAR
0.087  (0.009) 0.258  (0.014)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00
Hide Arm/Group Description Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
All-Cause Mortality
TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/148 (3.38%)      11/151 (7.28%)    
Eye disorders     
Cystoid Macular Edema  1  2/148 (1.35%)  2 5/151 (3.31%)  5
Pupillary Capture  1  1/148 (0.68%)  1 0/151 (0.00%)  0
Endophthalmitis  1  1/148 (0.68%)  1 0/151 (0.00%)  0
Hypopyon  1  1/148 (0.68%)  1 0/151 (0.00%)  0
Epiretinal Membrane Peel  1  0/148 (0.00%)  0 1/151 (0.66%)  1
Anterior Ischemic Optic Neuropathy  1  0/148 (0.00%)  0 1/151 (0.66%)  1
Lens Fragment  1 [1]  0/148 (0.00%)  0 2/151 (1.32%)  2
Anterior Basement Membrane Distrophy  1  0/148 (0.00%)  0 1/151 (0.66%)  1
Inflammation  1 [2]  0/148 (0.00%)  0 1/151 (0.66%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
[1]
Requiring fragment removal
[2]
Requiring treatment injection
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TECNIS Intraocular Lens, Model ZXR00 TECNIS Intraocular Lens, Model ZCB00
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/148 (0.00%)      0/151 (0.00%)    
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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kendra Hileman, Ph.D., Director of Clinical Research and Development
Organization: Abbott Medical Optics
Phone: 714-247-8613
EMail: kendra.hileman@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02203721    
Other Study ID Numbers: EROV-106-ZXRC
First Submitted: July 24, 2014
First Posted: July 30, 2014
Results First Submitted: September 28, 2016
Results First Posted: January 11, 2017
Last Update Posted: January 11, 2017