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Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

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ClinicalTrials.gov Identifier: NCT00747565
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : December 2, 2010
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: Tecnis ZM900 Multifocal Intraocular Lens
Device: CeeOn 911A monofocal IOL
Enrollment 470
Recruitment Details Multifocal and monofocal control subjects were enrolled in the original study in 2004-2005 from the normal cataract populations at 13 USA sites. In the expansion study, additional multifocal subjects were enrolled from the normal cataract populations at 16 USA sites (13 who also participated in the original study) in 2007.
Pre-assignment Details Subjects chose which type of lens to receive (multifocal or monofocal) in the original study. Subjects only received the multifocal lens in the expansion study.
Arm/Group Title Tecnis Multifocal Subjects Monofocal Control Subjects
Hide Arm/Group Description Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Period Title: Overall Study
Started 347 [1] 123
Completed 333 [2] 116
Not Completed 14 7
Reason Not Completed
Withdrawal by Subject             10             6
Lost to Follow-up             4             1
[1]
125 multifocal subjects in original study plus 222 multifocal subjects in the expansion study.
[2]
118 multifocal subjects in the original study plus 215 multifocal subejcts in the expansion study.
Arm/Group Title Tecnis Multifocal Subjects Monofocal Control Subjects Total
Hide Arm/Group Description Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints. Total of all reporting groups
Overall Number of Baseline Participants 347 123 470
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants 123 participants 470 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
144
  41.5%
27
  22.0%
171
  36.4%
>=65 years
203
  58.5%
96
  78.0%
299
  63.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 347 participants 123 participants 470 participants
65.9  (9.5) 68.7  (8.9) 66.7  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants 123 participants 470 participants
Female
211
  60.8%
81
  65.9%
292
  62.1%
Male
136
  39.2%
42
  34.1%
178
  37.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 347 participants 123 participants 470 participants
347 123 470
1.Primary Outcome
Title Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
Hide Description Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
First eye results from subjects at one year in both the original study and the expansion study combined.
Arm/Group Title Tecnis Multifocal Subjects Monofocal Control Subjects
Hide Arm/Group Description:
Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Overall Number of Participants Analyzed 331 114
Measure Type: Number
Unit of Measure: Participants (First Eyes only)
329 114
2.Primary Outcome
Title Mean Binocular Distance Corrected Near Visual Acuity in Snellen
Hide Description Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Binocular subjects at one year available for testing for both studies combined.
Arm/Group Title Tecnis Multifocal Subjects Monofocal Control Subjects
Hide Arm/Group Description:
Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Overall Number of Participants Analyzed 291 113
Mean (Standard Deviation)
Unit of Measure: Mean Snellen Line (with ETDRS line SD)
24  (1.09) 70  (1.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecnis Multifocal Subjects, Monofocal Control Subjects
Comments ETDRS line scores used for statistical comparisons with mean Snellen values reported above.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tecnis Multifocal Subjects Monofocal Control Subjects
Hide Arm/Group Description Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects. Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
All-Cause Mortality
Tecnis Multifocal Subjects Monofocal Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tecnis Multifocal Subjects Monofocal Control Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/348 (4.02%)      1/123 (0.81%)    
Eye disorders     
Endophthalmitis, hypopyon and surgical intervention *  1/348 (0.29%)  5 0/123 (0.00%)  0
Signifcant loss in vision due to stroke *  1/348 (0.29%)  1 0/123 (0.00%)  0
Lens-related lens removal   1/348 (0.29%)  1 0/123 (0.00%)  0
Lens-related other surgical procedures   1/348 (0.29%)  1 0/123 (0.00%)  0
Non-lens-related lens exchange   4/348 (1.15%)  4 0/123 (0.00%)  0
Non-lens-related other surgical procedures   6/348 (1.72%)  6 1/123 (0.81%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tecnis Multifocal Subjects Monofocal Control Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/348 (0.00%)      0/123 (0.00%)    
Results from the original study (DIOL-101-TCNS) and the expansion study (DIOL-104-TCNS) were analyzed together. The original study enrolled both multifocal and monofocal control subjects; the expansion study enrolled additional multifocal subjects.
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.
PIs may not publish or disclose study data without Sponsor's prior written approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicholas Tarantino, O.D., Head, Global Clinical Research & Development
Organization: Abbott Medical Optics, Inc.
Phone: 866-427-8477 ext 8613
EMail: nicholas.tarantino@amo.abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00747565     History of Changes
Other Study ID Numbers: DIOL-104-TCNS & DIOL-101-TCNS
First Submitted: September 3, 2008
First Posted: September 5, 2008
Results First Submitted: August 14, 2009
Results First Posted: December 2, 2010
Last Update Posted: March 4, 2013