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Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens
NA trial testing ACRYSOF IQ PanOptix Toric Trifocal IOL in Aphakia in 32 participants. Completed in 10 August 2021.
| Lead sponsor | Alcon Research |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 1 December 2020 |
| Primary completion | 10 August 2021 |
| Estimated completion | 10 August 2021 |
| Sites | 1 location across Japan |
Alcon Research — full company profile →
20 and older, any sex, with Aphakia or Corneal Astigmatism. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| PanOptix Toric Trifocal IOL | 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.
| Group | Value | 95% CI |
|---|---|---|
| PanOptix Toric Trifocal IOL | 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.
| Group | Value | 95% CI |
|---|---|---|
| PanOptix Toric Trifocal IOL | 0.055 | ± 0.153 |
Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pretreatment | TFNT20 Ocular / First Eye | TFNT20 Ocular / Second Eye | TFNT20 Nonocular / Systemic |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | — | — | — | — |
Data from ClinicalTrials.gov NCT04542525 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing