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The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.
Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.
This study will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanOptix Toric Trifocal IOL | Experimental | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACRYSOF IQ PanOptix Toric Trifocal IOL | Device | Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. | Day 30-60 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. | Day 30-60 postoperative |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA Surgical | Alcon Japan Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Chiyoda-Ku | Tokyo | 101-0061 | Japan |
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This reporting group includes all enrolled participants.
Subjects were recruited from 1 investigative site located in Japan.
| ID | Title | Description |
|---|---|---|
| FG000 | PanOptix Toric Trifocal IOL | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All Implanted Analysis Set: All eyes with successful test article implantation
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| ID | Title | Description |
|---|---|---|
| BG000 | PanOptix Toric Trifocal IOL | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. | All Implanted Analysis Set | Posted | Number | percentage of eyes | Day 30-60 postoperative | eyes | eyes |
|
|
Adverse events (AEs) were collected pre-treatment (Day -60 to 0) up to Day 30-60 post-treatment/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | Events reported in this group occurred prior to attempted implantation with the test article |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Projects, Surgical | Alcon Research, LLC | +1-817-909-6199 | jessie.hull@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2021 | Jul 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2020 | Jul 22, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D001251 | Astigmatism |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Cataract surgery | Procedure | Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use |
|
| Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. | Day 30-60 postoperative |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | participants | No |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| eyes |
|
|
|
| Secondary | Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. | All Implanted Analysis Set | Posted | Number | percentage of eyes | Day 30-60 postoperative | eyes | eyes |
|
|
|
| Secondary | Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. | All Implanted Analysis Set | Posted | Mean | Standard Deviation | diopter | Day 30-60 postoperative | eyes | eyes |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | TFNT20 Ocular / First Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye | 0 | 32 | 0 | 32 | 5 | 32 |
| EG002 | TFNT20 Ocular / Second Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye | 0 | 9 | 0 | 9 | 1 | 9 |
| EG003 | TFNT20 Nonocular / Systemic | Events reported in this group occurred after attempted implantation with the test article | 0 | 32 | 0 | 32 | 0 | 32 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.