Trial Outcomes & Findings for Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction (NCT NCT04224155)
NCT ID: NCT04224155
Last Updated: 2024-10-10
Results Overview
All serious adverse events through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
Day 120 to Day 180 after second eye IOL implantation
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
Subjects assigned to enVista MX60EFH trifocal intraocular lenses (IOLs)
|
enVista MX60E Monofocal Intraocular Lens (IOL)
Subjects assigned to enVista MX60E monofocal intraocular lenses (IOLs)
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
54
|
|
Overall Study
COMPLETED
|
110
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
Baseline characteristics by cohort
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=222 Eyes
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=107 Eyes
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
Total
n=329 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 7.77 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 7.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
111 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationAll serious adverse events through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=111 Participants
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=54 Participants
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Serious Adverse Events
Diverticulitis
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events
Neck pain
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events
Neoplasm malignant
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events
Cerebrovascular accident
|
0 Participants
|
1 Participants
|
|
Serious Adverse Events
Dry age-related macular degeneration
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationThe cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens, through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). The rate was determined as the number of eyes with an SSI related to the optical properties of the IOL divided by the total number of eyes.
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=222 Eyes
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=107 Eyes
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Cumulative Rate of Secondary Surgical Interventions Due to the Optical Properties of the Lens
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationPopulation: Per Protocol Set
Photopic uncorrected distance visual acuity (UDVA) for first implanted eyes at 4 m at Post.Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=108 Participants
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=50 Participants
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Photopic Uncorrected Distance Visual Acuity (UDVA) for First Implanted Eyes
|
0.121 logMAR
Standard Deviation 0.1343
|
0.044 logMAR
Standard Deviation 0.1224
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationPhotopic uncorrected near and intermediate visual acuity (UNVA and UIVA) for first implanted eyes at 40 cm and 66 cm, respectively, at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=111 Participants
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=54 Participants
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Photopic Uncorrected Near and Intermediate Visual Acuity (UNVA and UIVA) for First Implanted Eyes at 40 cm and 66 cm, Respectively
UNVA
|
0.210 logMAR
Standard Deviation 0.1294
|
0.476 logMAR
Standard Deviation 0.1587
|
|
Photopic Uncorrected Near and Intermediate Visual Acuity (UNVA and UIVA) for First Implanted Eyes at 40 cm and 66 cm, Respectively
UIVA
|
0.163 logMAR
Standard Deviation 0.1247
|
0.286 logMAR
Standard Deviation 0.1543
|
PRIMARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationThe incidence of adverse events (AEs), through Postoperative Visit 4 (Day 120 to Day 180 after second eye IOL implantation), compared to ISO Safety and Performance Endpoint rates as defined in ISO 11979-7:2018 and EN ISO 11979-7:2018 Annex E. The observed AE rate was calculated as 100 multiplied by the number of eyes with the specific treatment-emergent event divided by the number of implanted eyes.
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=222 Eyes
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
Cystoid macular oedema
|
3 Eyes
|
—
|
|
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
Hypopyon
|
0 Eyes
|
—
|
|
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
Endophthalmitis
|
0 Eyes
|
—
|
|
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
Lens dislocated from posterior chamber
|
0 Eyes
|
—
|
|
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
Pupillary block
|
0 Eyes
|
—
|
|
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
Retinal detachment
|
0 Eyes
|
—
|
|
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
SSI
|
0 Eyes
|
—
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationPopulation: PRO Analysis Set
The incidence of Patient-Reported Outcomes Set subjects experiencing at least one severe visual disturbance, defined as the highest grade of severity or bothersomeness (separately) reported by subjects using the Quality of Vision (QoV) questionnaire at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Incidence was calculated as 100 multiplied by Count of Participants experiencing at least one severe visual disturbance divided by Number of Participants Analyzed.
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=110 Participants
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=52 Participants
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Incidence of Subjects Experiencing at Least One Severe Visual Disturbance
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationPhotopic contrast sensitivity with glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular photopic (approximately 85 cd/m2) contrast sensitivity with glare was tested at spatial frequencies of 3, 6, 12 and 18 cycles per degree (cpd) and was assessed in log units.
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=64 eyes
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=18 eyes
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 3 cpd
|
1.703 log value
Standard Deviation 0.3497
|
1.965 log value
Standard Deviation 0.3259
|
|
Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 6 cpd
|
1.544 log value
Standard Deviation 0.2989
|
1.894 log value
Standard Deviation 0.3325
|
|
Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 12 cpd
|
1.249 log value
Standard Deviation 0.3330
|
1.366 log value
Standard Deviation 0.3475
|
|
Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 18 cpd
|
0.749 log value
Standard Deviation 0.3483
|
1.016 log value
Standard Deviation 0.3203
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationMesopic contrast sensitivity with glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular mesopic (2.5 to 3.2 cd/m2) contrast sensitivity with glare was tested at spatial frequencies of 1.5, 3, 6 and 12 cpd and was assessed in log units.
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=64 eyes
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=18 eyes
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 1.5 cpd
|
1.534 log value
Standard Deviation 0.3585
|
1.701 log value
Standard Deviation 0.3113
|
|
Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 3 cpd
|
1.552 log value
Standard Deviation 0.3405
|
1.884 log value
Standard Deviation 0.2853
|
|
Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 6 cpd
|
1.188 log value
Standard Deviation 0.3020
|
1.577 log value
Standard Deviation 0.2668
|
|
Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4
At 12 cpd
|
0.605 log value
Standard Deviation 0.3235
|
0.882 log value
Standard Deviation 0.2936
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationMesopic contrast sensitivity without glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular mesopic (2.5 to 3.2 cd/m2) contrast sensitivity without glare was tested at spatial frequencies of 1.5, 3, 6 and 12 cpd and was assessed in log units.
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=64 eyes
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=18 eyes
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4
At 1.5 cpd
|
2.024 log value
Standard Deviation 0.2661
|
1.943 log value
Standard Deviation 0.4097
|
|
Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4
At 3 cpd
|
1.999 log value
Standard Deviation 0.2995
|
2.100 log value
Standard Deviation 0.3775
|
|
Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4
At 6 cpd
|
1.574 log value
Standard Deviation 0.3156
|
1.753 log value
Standard Deviation 0.4634
|
|
Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4
At 12 cpd
|
0.881 log value
Standard Deviation 0.3646
|
1.014 log value
Standard Deviation 0.3298
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationIOL rotation for all eyes at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=222 Eyes
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
IOL Rotation for All Eyes at Post-Operative Visit 4
|
2.21 degrees
Standard Deviation 2.501
|
—
|
SECONDARY outcome
Timeframe: Day 120 to Day 180 after second eye IOL implantationChange from baseline ( preoperative ) in uncorrected photopic near and intermediate visual acuity (UNVA and UIVA) at 40 cm and 66 cm, respectively, for first implanted eyes to Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Outcome measures
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=111 Participants
enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=54 Participants
enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
|
|---|---|---|
|
Change From Baseline ( Preoperative ) in Uncorrected Photopic Near and Intermediate Visual Acuity (UNVA and UIVA) at 40 cm and 66 cm, Respectively, for First Implanted Eyes to Post-Operative Visit 4
UNVA
|
-0.502 logMAR
Standard Deviation 0.2947
|
-0.157 logMAR
Standard Deviation 0.3062
|
|
Change From Baseline ( Preoperative ) in Uncorrected Photopic Near and Intermediate Visual Acuity (UNVA and UIVA) at 40 cm and 66 cm, Respectively, for First Implanted Eyes to Post-Operative Visit 4
UIVA
|
-0.505 logMAR
Standard Deviation 0.2983
|
-0.305 logMAR
Standard Deviation 0.3216
|
Adverse Events
enVista MX60EFH Trifocal Intraocular Lens (IOL)
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
enVista MX60E Monofocal Intraocular Lens (IOL)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=111 participants at risk
Subjects implanted with enVista MX60EFH trifocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 222 for the enVista MX60EFH trifocal intraocular lens (IOL) group.
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=54 participants at risk
Subjects implanted with enVista MX60E monofocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 107 for the enVista MX60E monofocal intraocular lens (IOL) group.
|
|---|---|---|
|
Eye disorders
Dry age-related macular degeneration
|
0.90%
1/111 • Number of events 1 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
0.00%
0/54 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
|
Infections and infestations
Diverticulitis
|
0.90%
1/111 • Number of events 1 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
0.00%
0/54 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.90%
1/111 • Number of events 1 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
0.00%
0/54 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.90%
1/111 • Number of events 1 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
0.00%
0/54 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/111 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
1.9%
1/54 • Number of events 1 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
Other adverse events
| Measure |
enVista MX60EFH Trifocal Intraocular Lens (IOL)
n=111 participants at risk
Subjects implanted with enVista MX60EFH trifocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 222 for the enVista MX60EFH trifocal intraocular lens (IOL) group.
|
enVista MX60E Monofocal Intraocular Lens (IOL)
n=54 participants at risk
Subjects implanted with enVista MX60E monofocal intraocular lenses (IOLs). For ocular AEs, the number of eyes at risk were 107 for the enVista MX60E monofocal intraocular lens (IOL) group.
|
|---|---|---|
|
Eye disorders
Punctate keratitis
|
18.9%
21/111 • Number of events 29 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
14.8%
8/54 • Number of events 10 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
|
Eye disorders
Visual Acuity Reduced
|
1.8%
2/111 • Number of events 2 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
7.4%
4/54 • Number of events 5 • Day 120 to Day 180 after second eye IOL implantation
Ocular Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact Sponsor directly for details
- Publication restrictions are in place
Restriction type: OTHER