Aphakia, Astigmatism, Presbyopia
Conditions
Keywords
cataract
Brief summary
This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.
Detailed description
If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 20 days of the first eye surgery. Four postoperative follow-up visits are planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. Subject participation in this study is expected to last up to 7 months, including a total of 6 study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the study.
Interventions
DEVICEACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
DEVICEACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
DEVICEACRYSOF IQ RESTOR +2.5 D Multifocal IOL
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
PROCEDURECataract Surgery
Routine small incision cataract surgery with IOL implantation
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Arm 1 completed prior to the initiation of Arm 2. Within each arm, IOL assignment was parallel.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Preoperative cataract in the study eye(s) * Planned implantation in at least one eye with: * Cohort 1: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling from November 2018 to July 2020 * Cohort 2: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 2020. * Able to comprehend and sign a statement of informed consent * Willing and able to complete all required postoperative visits * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Eyes with clinically significant ocular, including adnexa, or intraocular infection or inflammation (at the screening visit prior to surgery or on the day of surgery) * History of any intraocular inflammation within the past 12 months (ex: uveitis, choroiditis) * Combined procedures introducing an additional medical device during cataract surgery (ex: cataract surgery with implant of glaucoma stent) * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. | Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. | Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2 | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2 | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2 | Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. | TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
| Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2 | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Subjects were enrolled at 37 investigative sites located in the United States and 1 investigative site located in Puerto Rico.
Pre-assignment details
Cohort 1: Of the 478 enrolled, 25 subjects discontinued prior to attempted implantation. Cohort 2: Of the 1971 enrolled, 144 subjects discontinued prior to attempted implantation. This reporting group includes all enrolled subjects/eyes with attempted implantation (453/706 in Cohort 1) (1827/3417 in Cohort 2).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery. | 453 |
| Cohort 2 ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in at least one eye during cataract surgery. | 1,792 |
| Total | 2,245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Death | 0 | 5 |
| Overall Study | Lost to Follow-up | 1 | 32 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 8 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Customized Equal to or greater than 65 years | 305 participants | 1360 participants | 1665 participants |
| Age, Customized Less that 65 years | 148 participants | 432 participants | 580 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 14 participants | 15 participants |
| Race/Ethnicity, Customized Asian | 83 participants | 88 participants | 171 participants |
| Race/Ethnicity, Customized Black or African American | 28 participants | 266 participants | 294 participants |
| Race/Ethnicity, Customized Multi-Racial | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 6 participants | 6 participants |
| Race/Ethnicity, Customized Other | 3 participants | 29 participants | 32 participants |
| Race/Ethnicity, Customized White | 336 participants | 1387 participants | 1723 participants |
| Sex: Female, Male Female | 274 Participants | 1150 Participants | 1424 Participants |
| Sex: Female, Male Male | 179 Participants | 642 Participants | 821 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 453 | 0 / 453 | 0 / 253 | 0 / 453 | 0 / 1,827 | 0 / 1,827 | 0 / 1,590 | 7 / 1,827 |
| other Total, other adverse events | 2 / 453 | 71 / 453 | 31 / 253 | 0 / 453 | 0 / 1,827 | 0 / 1,827 | 0 / 1,590 | 0 / 1,827 |
| serious Total, serious adverse events | 0 / 453 | 4 / 453 | 6 / 253 | 8 / 453 | 5 / 1,827 | 27 / 1,827 | 17 / 1,590 | 28 / 1,827 |
Outcome results
Primary
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | 5.6 event rate per 1000 implants |
| Second Eye | Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | 4.5 event rate per 1000 implants |
Primary
Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | 5.1 event rate per 1000 implants |
Secondary
Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2 | 0.0 event rate per 1000 implants |
| Second Eye | Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2 | 0.6 event rate per 1000 implants |
Secondary
Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | 0.3 event rate per 1000 implants |
Secondary
Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2 | 0.0 event rate per 1000 implants |
| Second Eye | Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2 | 0.0 event rate per 1000 implants |
Secondary
Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | 0.0 event rate per 1000 implants |
Secondary
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2 | 1.1 event rate per 1000 implants |
| Second Eye | Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2 | 0.0 event rate per 1000 implants |
Secondary
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2 | 0.6 event rate per 1000 implants |
Secondary
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | 4.5 event rate per 1000 implants |
| Second Eye | Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | 3.8 event rate per 1000 implants |
Secondary
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Eye | Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | 4.2 event rate per 1000 implants |