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Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

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ClinicalTrials.gov Identifier: NCT03280108
Recruitment Status : Completed
First Posted : September 12, 2017
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: AcrySof IQ PanOptix Multifocal IOL
Device: AcrySof Monofocal IOL
Enrollment 250
Recruitment Details Subjects were recruited from 12 investigative sites located in the United States.
Pre-assignment Details Of the 250 enrolled, 7 subjects were exited as screen failures prior to attempted implantation. This reporting group includes all subjects with at least one eye implanted (243).
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Period Title: Overall Study
Started [1] 129 114
Completed 127 114
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
[1]
Successful Implantation
Arm/Group Title TFNT00 SN60AT Total
Hide Arm/Group Description AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. Total of all reporting groups
Overall Number of Baseline Participants 129 114 243
Hide Baseline Analysis Population Description
This analysis population includes all eyes with successful IOL implantation with at least 1 post-operative visit (All-Implanted Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 114 participants 243 participants
65.8  (7.31) 69.0  (6.46) 67.3  (7.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 114 participants 243 participants
Female
85
  65.9%
79
  69.3%
164
  67.5%
Male
44
  34.1%
35
  30.7%
79
  32.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 129 participants 114 participants 243 participants
White
113
  87.6%
96
  84.2%
209
  86.0%
Black or African American
8
   6.2%
11
   9.6%
19
   7.8%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
   5.4%
1
   0.9%
8
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.8%
2
   0.8%
Other
1
   0.8%
4
   3.5%
5
   2.1%
1.Primary Outcome
Title Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)
Hide Description Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All-Implanted Analysis Set with data available at the visit
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 113
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
-0.014  (0.0083) -0.039  (0.0087)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.024
Confidence Interval (1-Sided) 95%
0.041
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0103
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)
Hide Description VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All-Implanted Analysis Set with data at visit
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 113
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 127 113
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
0.105  (0.0119) 0.529  (0.0127)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye
Hide Description The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.
Time Frame Up to Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set).
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 129 114
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 129 114
Count of Units
Unit of Measure: Eyes
1
   0.8%
0
   0.0%
4.Primary Outcome
Title Mean Photopic Without Glare Binocular Distance Contrast Sensitivity
Hide Description Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set with contrast sensitivity test
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 111
Mean (Standard Deviation)
Unit of Measure: log units
3 cpd 1.752  (0.2080) 1.733  (0.1989)
6 cpd 1.923  (0.2349) 1.940  (0.2328)
12 cpd 1.527  (0.2793) 1.558  (0.2566)
18 cpd 0.993  (0.2874) 1.090  (0.2661)
5.Primary Outcome
Title Mean Photopic With Glare Binocular Distance Contrast Sensitivity
Hide Description Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set with contrast sensitivity test
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 111
Mean (Standard Deviation)
Unit of Measure: log units
3 cpd 1.759  (0.1890) 1.753  (0.1928)
6 cpd 1.897  (0.2322) 1.971  (0.1952)
12 cpd 1.566  (0.2728) 1.593  (0.2659)
18 cpd 1.037  (0.2762) 1.121  (0.2537)
6.Primary Outcome
Title Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity
Hide Description Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set with contrast sensitivity test
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 111
Mean (Standard Deviation)
Unit of Measure: log units
1.5 cpd 1.673  (0.2601) 1.679  (0.2190)
3 cpd 1.717  (0.2397) 1.689  (0.2177)
6 cpd 1.715  (0.2875) 1.777  (0.2871)
12 cpd 1.211  (0.4047) 1.290  (0.4384)
7.Primary Outcome
Title Mean Mesopic With Glare Binocular Distance Contrast Sensitivity
Hide Description Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set with contrast sensitivity test
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 111
Mean (Standard Deviation)
Unit of Measure: log units
1.5 cpd 1.658  (0.2296) 1.678  (0.2091)
3 cpd 1.709  (0.2307) 1.692  (0.2089)
6 cpd 1.691  (0.3238) 1.786  (0.2775)
12 cpd 1.129  (0.4146) 1.233  (0.4599)
8.Secondary Outcome
Title Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)
Hide Description VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All-Implanted Analysis Set with data at visit
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 113
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
 127 113
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
0.070  (0.0108) 0.327  (0.0114)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.257
Confidence Interval (2-Sided) 95%
-0.287 to -0.227
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0153
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire
Hide Description The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects with bilateral implantation and concordant, non-missing data.
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 123 110
Measure Type: Number
Unit of Measure: percentage of subjects
80.5 8.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mantel-Haenszel common difference
Estimated Value 71.2
Confidence Interval (2-Sided) 95%
61.87 to 80.46
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)
Hide Description QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects with bilateral implantation and non-missing data.
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 111
Measure Type: Count of Participants
Unit of Measure: Participants
Starbursts Number Analyzed 125 participants 109 participants
20
  16.0%
2
   1.8%
Halos Number Analyzed 127 participants 110 participants
16
  12.6%
1
   0.9%
Glare Number Analyzed 126 participants 111 participants
4
   3.2%
2
   1.8%
Hazy vision Number Analyzed 125 participants 110 participants
0
   0.0%
0
   0.0%
Blurred vision Number Analyzed 127 participants 111 participants
0
   0.0%
0
   0.0%
Double vision Number Analyzed 125 participants 110 participants
0
   0.0%
0
   0.0%
Dark area Number Analyzed 127 participants 111 participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID
Hide Description Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
Time Frame Month 6 (Day 120-180), post second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects with bilateral implantation and non-missing data.
Arm/Group Title TFNT00 SN60AT
Hide Arm/Group Description:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Number of Participants Analyzed 127 111
Measure Type: Count of Participants
Unit of Measure: Participants
Starbursts Number Analyzed 125 participants 109 participants
6
   4.8%
1
   0.9%
Halos Number Analyzed 127 participants 110 participants
3
   2.4%
1
   0.9%
Glare Number Analyzed 126 participants 111 participants
2
   1.6%
1
   0.9%
Hazy vision Number Analyzed 125 participants 110 participants
0
   0.0%
1
   0.9%
Blurred vision Number Analyzed 127 participants 111 participants
0
   0.0%
2
   1.8%
Double vision Number Analyzed 125 participants 110 participants
0
   0.0%
0
   0.0%
Dark area Number Analyzed 127 participants 111 participants
0
   0.0%
0
   0.0%
Time Frame Implantation through study completion, an average of 7 months
Adverse Event Reporting Description Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
 
Arm/Group Title Preoperative TFNT00 - 1st Eye TFNT00 - 2nd Eye TFNT00 - Systemic SN60AT - 1st Eye SN60AT - 2nd Eye SN60AT - Systemic
Hide Arm/Group Description All subjects in the safety analysis set prior to initiation of treatment. All first study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00. All second study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00. All subjects implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00. All first study eyes implanted with AcrySof Monofocal IOL Model SN60AT. All second study eyes implanted with AcrySof Monofocal IOL Model SN60AT. All subjects implanted with AcrySof Monofocal IOL Model SN60AT.
All-Cause Mortality
Preoperative TFNT00 - 1st Eye TFNT00 - 2nd Eye TFNT00 - Systemic SN60AT - 1st Eye SN60AT - 2nd Eye SN60AT - Systemic
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/243 (0.00%)   0/129 (0.00%)   0/127 (0.00%)   0/129 (0.00%)   0/114 (0.00%)   0/111 (0.00%)   0/114 (0.00%) 
Hide Serious Adverse Events
Preoperative TFNT00 - 1st Eye TFNT00 - 2nd Eye TFNT00 - Systemic SN60AT - 1st Eye SN60AT - 2nd Eye SN60AT - Systemic
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/243 (0.00%)   2/129 (1.55%)   2/127 (1.57%)   4/129 (3.10%)   2/114 (1.75%)   1/111 (0.90%)   3/114 (2.63%) 
Cardiac disorders               
Acute myocardial infarction † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  1/129 (0.78%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Eye disorders               
Age-related macular degeneration † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  0/129 (0.00%)  1/114 (0.88%)  1/111 (0.90%)  0/114 (0.00%) 
Cystoid macular oedema † 1  0/243 (0.00%)  0/129 (0.00%)  1/127 (0.79%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Posterior capsule rupture † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  0/129 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Vitreous prolapse † 1  0/243 (0.00%)  0/129 (0.00%)  1/127 (0.79%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Retinal tear † 1  0/243 (0.00%)  1/129 (0.78%)  0/127 (0.00%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Gastrointestinal disorders               
Abdominal wall haematoma † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  1/129 (0.78%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Ileus † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  1/129 (0.78%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Hepatobiliary disorders               
Cholecystitis acute † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Cholelithiasis † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  1/129 (0.78%)  0/114 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Infections and infestations               
Diverticulitis † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  1/129 (0.78%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Breast neoplasm † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Product Issues               
Device dislocation † 1  0/243 (0.00%)  0/129 (0.00%)  1/127 (0.79%)  0/129 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Renal and urinary disorders               
Acute kidney injury † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Surgical and medical procedures               
Colectomy † 1  0/243 (0.00%)  0/129 (0.00%)  0/127 (0.00%)  1/129 (0.78%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Intra-ocular injection † 1  0/243 (0.00%)  1/129 (0.78%)  2/127 (1.57%)  1/129 (0.78%)  1/114 (0.88%)  1/111 (0.90%)  0/114 (0.00%) 
Intraocular lens repositioning † 1  0/243 (0.00%)  0/129 (0.00%)  1/127 (0.79%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Lens extraction † 1  0/243 (0.00%)  1/129 (0.78%)  0/127 (0.00%)  0/129 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Vitrectomy † 1  0/243 (0.00%)  0/129 (0.00%)  1/127 (0.79%)  0/129 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Preoperative TFNT00 - 1st Eye TFNT00 - 2nd Eye TFNT00 - Systemic SN60AT - 1st Eye SN60AT - 2nd Eye SN60AT - Systemic
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/243 (0.41%)   24/129 (18.60%)   24/127 (18.90%)   0/129 (0.00%)   10/114 (8.77%)   7/111 (6.31%)   0/114 (0.00%) 
Eye disorders               
Posterior capsule opacification † 1  0/243 (0.00%)  17/129 (13.18%)  19/127 (14.96%)  0/129 (0.00%)  4/114 (3.51%)  5/111 (4.50%)  0/114 (0.00%) 
Investigations               
Intraocular pressure increased † 1  1/243 (0.41%)  7/129 (5.43%)  5/127 (3.94%)  0/129 (0.00%)  6/114 (5.26%)  2/111 (1.80%)  0/114 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
†
Indicates events were collected by systematic assessment
[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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
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Name/Title: Expert Clinical Project Lead, CDMA Surgical
Organization: Alcon Research
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03280108    
Other Study ID Numbers: ILH297-C001
First Submitted: September 6, 2017
First Posted: September 12, 2017
Results First Submitted: September 19, 2019
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019