An interventional study of ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL and ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL in Aphakia, Presbyopia and Astigmatism, sponsored by Alcon Research. Completed at 38 sites in 2 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 2,449 is above the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Planned implantation in at least one eye with:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery, with implantation occurring from November 2018 through July 2020.
Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL · Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL · Procedure: Cataract Surgery
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, with implantation occurring after July 2020.
Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL · Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL · Procedure: Cataract Surgery
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.
Also known as: Models SND1T3, SND1T4, SND1T5, and SND1T6
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.
Also known as: Models SV25T3, SV25T4, SV25T5, and SV25T6
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.
Also known as: Model SV25T0
Routine small incision cataract surgery with IOL implantation
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.
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.
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.
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
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
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
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
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
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
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
Subjects were enrolled at 37 investigative sites located in the United States and 1 investigative site located in Puerto Rico.
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 453 | 1827 |
| First eye attempted implantation | 453 | 1827 |
| First eye successful implantation | 453 | 1827 |
| Second eye attempted implantation | 453 | 1827 |
| Second eye successful implantation | 453 | 1827 |
| Safety analysis set | 453 | 1827 |
| Completed | 451 | 1778 |
| Not completed | 2 | 49 |
| Withdrew: Lost to follow-up | 1 | 32 |
| Withdrew: Other | 1 | 0 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Death | 0 | 5 |
| Withdrew: Withdrawal by subject | 0 | 8 |
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.
| event rate per 1000 implants | First Eye | Second Eye |
|---|---|---|
| Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | 5.6 | 4.5 |
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.
| event rate per 1000 implants | Overall Eyes |
|---|---|
| Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | 5.1 (2.95 to 8.10) |
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.
| event rate per 1000 implants | First Eye | Second Eye |
|---|---|---|
| Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2 | 1.1 | 0.0 |
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.
| event rate per 1000 implants | Overall Eyes |
|---|---|
| Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2 | 0.6 (0.07 to 2.15) |
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.
| event rate per 1000 implants | First Eye | Second Eye |
|---|---|---|
| Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2 | 0.0 | 0.6 |
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.
| event rate per 1000 implants | Overall Eyes |
|---|---|
| Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | 0.3 (0.01 to 1.66) |
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.
| event rate per 1000 implants | First Eye | Second Eye |
|---|---|---|
| Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2 | 0.0 | 0.0 |
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.
| event rate per 1000 implants | Overall Eyes |
|---|---|
| Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | 0.0 (0.00 to 1.10) |
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.
| event rate per 1000 implants | First Eye | Second Eye |
|---|---|---|
| Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | 4.5 | 3.8 |
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.
| event rate per 1000 implants | Overall |
|---|---|
| Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | 4.2 (2.28 to 6.99) |
Collected over Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 Pretreatment | 0/453 (0%) | 0/453 (0%) | 2/453 (0.4%) |
| Cohort 1 Ocular - First Eye | 0/453 (0%) | 4/453 (0.9%) | 71/453 (15.7%) |
| Cohort 1 Ocular - Second Eye | 0/253 (0%) | 6/253 (2.4%) | 31/253 (12.3%) |
| Cohort 1 Systemic | 0/453 (0%) | 8/453 (1.8%) | 0/453 (0%) |
| Cohort 2 Pretreatment | 0/1,827 (0%) | 5/1,827 (0.3%) | 0/1,827 (0%) |
| Cohort 2 Ocular - First Eye | 0/1,827 (0%) | 27/1,827 (1.5%) | 0/1,827 (0%) |
| Cohort 2 Ocular - Second Eye | 0/1,590 (0%) | 17/1,590 (1.1%) | 0/1,590 (0%) |
| Cohort 2 Systemic | 7/1,827 (0.4%) | 28/1,827 (1.5%) | 0/1,827 (0%) |
| Event | Cohort 1 Pretreatment | Cohort 1 Ocular - First Eye | Cohort 1 Ocular - Second Eye | Cohort 1 Systemic | Cohort 2 Pretreatment | Cohort 2 Ocular - First Eye | Cohort 2 Ocular - Second Eye | Cohort 2 Systemic |
|---|---|---|---|---|---|---|---|---|
| Punctate keratitisEye disorders | 0/453 | 2/453 | 1/253 | 0/453 | 0/1827 | 0/1827 | 0/1590 | 0/1827 |
| Corneal operationSurgical and medical procedures | 0/453 | 2/453 | 1/253 | 0/453 | 0/1827 | 2/1827 | 0/1590 | 0/1827 |
| VitrectomySurgical and medical procedures | 0/453 | 0/453 | 0/253 | 0/453 | 0/1827 | 8/1827 | 5/1590 | 0/1827 |
| Cystoid macular oedemaEye disorders | 0/453 | 1/453 | 1/253 | 0/453 | 0/1827 | 3/1827 | 1/1590 | 0/1827 |
| Retinal detachmentEye disorders | 0/453 | 0/453 | 1/253 | 0/453 | 0/1827 | 0/1827 | 5/1590 | 0/1827 |
| Retinal tearEye disorders | 0/453 | 0/453 | 1/253 | 0/453 | 0/1827 | 1/1827 | 2/1590 | 0/1827 |
| Vitreoretinal traction syndromeEye disorders | 0/453 | 0/453 | 1/253 | 0/453 | 0/1827 | 0/1827 | 0/1590 | 0/1827 |
| Cataract operation complicationInjury, poisoning and procedural complications | 0/453 | 0/453 | 1/253 | 0/453 | 0/1827 | 6/1827 | 4/1590 | 0/1827 |
| Visual field defectNervous system disorders | 0/453 | 0/453 | 1/253 | 0/453 | 0/1827 | 0/1827 | 0/1590 | 0/1827 |
| Device dislocationProduct Issues | 0/453 | 0/453 | 1/253 | 0/453 | 0/1827 | 4/1827 | 2/1590 | 0/1827 |
| Event | Cohort 1 Pretreatment | Cohort 1 Ocular - First Eye | Cohort 1 Ocular - Second Eye | Cohort 1 Systemic | Cohort 2 Pretreatment | Cohort 2 Ocular - First Eye | Cohort 2 Ocular - Second Eye | Cohort 2 Systemic |
|---|---|---|---|---|---|---|---|---|
| Posterior capsule opacificationEye disorders | 0/453 | 31/453 | 13/253 | 0/453 | 0/1827 | 0/1827 | 0/1590 | 0/1827 |
| Intraocular pressure increasedInvestigations | 0/453 | 27/453 | 11/253 | 0/453 | 0/1827 | 0/1827 | 0/1590 | 0/1827 |
| Dry eyeEye disorders | 2/453 | 23/453 | 11/253 | 0/453 | 0/1827 | 0/1827 | 0/1590 | 0/1827 |
Safety Analysis Set. Cohort 2 excluded one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Age, Customized(participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Less that 65 years | 148 | 432 | 580 |
| Equal to or greater than 65 years | 305 | 1360 | 1665 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 274 | 1150 | 1424 |
| Male | 179 | 642 | 821 |
| Race/Ethnicity, Customized(participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| White | 336 | 1387 | 1723 |
| Black or African American | 28 | 266 | 294 |
| American Indian or Alaska Native | 1 | 14 | 15 |
| Asian | 83 | 88 | 171 |
| Native Hawaiian or Other Pacific Islander | 0 | 6 | 6 |
| Multi-Racial | 2 | 2 | 4 |
| Other | 3 | 29 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2018 to primary completion in Oct 2022, 46 months.
Results were first posted in Nov 2023, 1 year after primary completion.
Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 46 months is above that.
Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.