An interventional study of ACRYSOF IQ PanOptix Toric Trifocal IOL and Cataract surgery in Aphakia and Corneal Astigmatism, sponsored by Alcon Research. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 32 is below 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.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Device: ACRYSOF IQ PanOptix Toric Trifocal IOL · Procedure: Cataract surgery
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
Also known as: PanOptix Toric Trifocal IOL, Model TFNT20
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
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.
Time frame: Day 30-60 postoperative
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.
Time frame: Day 30-60 postoperative
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.
Time frame: Day 30-60 postoperative
Subjects were recruited from 1 investigative site located in Japan.
| Milestone | PanOptix Toric Trifocal IOL |
|---|---|
| Started | 32 |
| Attempted implantation | 32 |
| Successful implantation | 32 |
| Completed | 32 |
| Not completed | 0 |
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.
| percentage of eyes | PanOptix Toric Trifocal IOL |
|---|---|
| Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | 90.2 |
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.
| percentage of eyes | PanOptix Toric Trifocal IOL |
|---|---|
| Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | 100 |
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.
| diopter | PanOptix Toric Trifocal IOL |
|---|---|
| Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) | 0.055 ± 0.153 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| TFNT20 Ocular / First Eye | 0/32 (0%) | 0/32 (0%) | 5/32 (15.6%) |
| TFNT20 Ocular / Second Eye | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| TFNT20 Nonocular / Systemic | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Event | Pretreatment | TFNT20 Ocular / First Eye | TFNT20 Ocular / Second Eye | TFNT20 Nonocular / Systemic |
|---|---|---|---|---|
| Intraocular pressure increasedInvestigations | 0/32 | 5/32 | 1/9 | 0/32 |
All Implanted Analysis Set: All eyes with successful test article implantation
| Age, Continuous(years) | PanOptix Toric Trifocal IOL |
|---|---|
| Mean | 65.2 ± 9.4 |
| Age, Customized(participants) | PanOptix Toric Trifocal IOL |
|---|---|
| Less than 60 years | 8 |
| 60-69 years | 10 |
| 70-79 years | 13 |
| 80 years and older | 1 |
| Sex: Female, Male(Participants) | PanOptix Toric Trifocal IOL |
|---|---|
| Female | 25 |
| Male | 7 |
| Race/Ethnicity, Customized(participants) | PanOptix Toric Trifocal IOL |
|---|---|
| Japanese | 32 |
| Region of Enrollment(participants) | PanOptix Toric Trifocal IOL |
|---|---|
| Japan | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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