AphakiaNCT03733730
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
A study testing ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL and ACRYSOF IQ RESTOR +2.5 D Multifocal IOL in people with Aphakia and Presbyopia, run by Alcon Research at 38 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Presbyopia, Astigmatism
- What is being tested?
- ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL and ACRYSOF IQ RESTOR +2.5 D Multifocal IOL
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,449 participants
- Where
- 38 sitesin 2 countries
- Study dates
- 27 Nov 2018to 14 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 exclusion criteria may apply.
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States37 sites
Kleinman Evangelista Eye Center of Texas
Arlington, Texas, 76018
Keystone Research
Austin, Texas, 78731
Chu Vision Institute
Bloomington, Minnesota, 55421
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Rand Eye Institute
Deerfield Beach, Florida, 33064
Central Florida Eye Specialists
DeLand, Florida, 32720
Trinity Research Group
Dothan, Alabama, 36301
El Paso Eye Surgeons
El Paso, Texas, 79902
Bergstrom Eye Research
Fargo, North Dakota, 58103
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
Chu Eye Institute
Fort Worth, Texas, 76107
InSight Vision Center
Fresno, California, 93720
Gainesville Eye Associates
Gainesville, Georgia, 30501
Houston Eye Associates
Houston, Texas, 77008
Berkeley Eye Center
Houston, Texas, 77027
Baylor College of Medicine Alkek Eye Center
Houston, Texas, 77030
Moyes Eye Center
Kansas City, Missouri, 64154
Harvard Eye Associates
Laguna Hills, California, 92653
Sabates Eye Center
Leawood, Kansas, 66211
Senior Health Services
Louisville, Kentucky, 40220
Piedmont Eye Center
Lynchburg, Virginia, 24501
Mid Florida Eye Center
Mt. Dora, Florida, 32757
Vision for Life
Nashville, Tennessee, 37205
Raymond Fong Eye Care
New York, New York, 10013
Durrie Vision
Overland Park, Kansas, 66210
Eye Doctors of Arizona
Phoenix, Arizona, 85003
Seeta Eye Center
Poughkeepsie, New York, 12603
Vistar Eye Center
Roanoke, Virginia, 24011
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Northwest Eye Surgeons
Seattle, Washington, 98133
Newsom Eye and Laser Center
Sebring, Florida, 33870
Willis-Knighton Eye Institute South
Shreveport, Louisiana, 71118
Carolina Eye Associates
Southern Pines, North Carolina, 28387
Associated Eye Care
Stillwater, Minnesota, 55082
SightTrust Eye Institute
Sunrise, Florida, 33323
Wolstan Goldberg Eye Associates
Torrance, California, 90505
St. Louis Eye Institute
Town and Country, Missouri, 63017
About this study
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.
Read the 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.
- Conditions
- Aphakia, Presbyopia, Astigmatism
- Being tested
- ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal IOL, Cataract Surgery
- Keywords
- cataract
- Medical subject headings
- Aphakia, Presbyopia, Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOLDevice
Also called 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.
ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLDevice
Also called 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, 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.
ACRYSOF IQ RESTOR +2.5 D Multifocal IOLDevice
Also called Model SV25T0
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.
Cataract SurgeryProcedure or surgery
Routine small incision cataract surgery with IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL; Procedure: Cataract Surgery |
| Cohort 2 | Experimental | 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. Receives: Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL; Procedure: Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start27 Nov 2018
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1 completed prior to the initiation of Arm 2. Within each arm, IOL assignment was parallel.
- Masking
- None (open label)
- Enrolment
- 2,449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, CRD Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733730
- Sponsor's protocol ID
- ILR431b-P001
- Other IDs
- P040020
- Status last verified
- Oct 2023
- First submitted
- 6 Nov 2018
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
- ClinicalTrials.gov ID
- NCT03733730
- Acronym / sponsor ID
- ILR431b-P001
- Conditions
- Aphakia, Presbyopia, Astigmatism
- Keywords
- cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,449 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1 completed prior to the initiation of Arm 2. Within each arm, IOL assignment was parallel.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL, Procedure: Cataract SurgeryACRYSOF 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. |
| Cohort 2 | Experimental | Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL, Procedure: Cataract SurgeryACRYSOF 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Preoperative cataract in the study eye(s)
- Planned implantation in at least one eye with:
- 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.
Key exclusion criteria (4 listed)
- 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 exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOLAlso: Models SND1T3, SND1T4, SND1T5, and SND1T6Intraocular 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. | Device | Cohort 1, Cohort 2 |
| ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLAlso: Models SV25T3, SV25T4, SV25T5, and SV25T6Intraocular 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. | Device | Cohort 1 |
| ACRYSOF IQ RESTOR +2.5 D Multifocal IOLAlso: Model SV25T0Intraocular 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. | Device | Cohort 2 |
| Cataract SurgeryRoutine small incision cataract surgery with IOL implantation | Procedure or surgery | Cohort 1, Cohort 2 |
Primary outcome
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Time frame: 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
Time frame: 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.
8 secondary outcomes
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
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
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
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
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
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
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
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
Time frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sr. Clinical Trial Lead, CRD Surgical study director
Alcon Research
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL and ACRYSOF IQ RESTOR +2.5 D Multifocal IOL in people with Aphakia and Presbyopia, run by Alcon Research at 38 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 (time frame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.