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Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
NA trial testing Higher Cylinder Toric IOL in Cataract in 475 participants. Completed in 8 August 2022.
| Lead sponsor | Johnson & Johnson Surgical Vision, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 475 |
| Start date | 13 December 2018 |
| Primary completion | 8 August 2022 |
| Estimated completion | 8 August 2022 |
| Sites | 23 locations across United States |
Johnson & Johnson Surgical Vision, Inc. — full company profile →
22 and older, any sex, with Cataract 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.
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
| Group | Value | 95% CI |
|---|---|---|
| Higher Cylinder Group | 19 | |
| Lower Cylinder Group | 19 |
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
| Group | Value | 95% CI |
|---|---|---|
| Higher Cylinder Group | 28 | |
| Lower Cylinder Group | 26 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Higher Cylinder Group | Lower Cylinder Group |
|---|---|---|---|
| Cystoid Macular Edema | Eye disorders | — | — |
| Elevated IOP requiring treatment | Eye disorders | — | — |
| Lens Axis Misalignment requiring SSI | Eye disorders | — | — |
| Hospitalization | General disorders | — | — |
| IOP Elevated Without Need for Treatment | Eye disorders | — | — |
| Undesirable Optical Phenomena | Eye disorders | — | — |
| Visual Symptoms requiring SSI | Eye disorders | — | — |
| IOP Greater than 10mmHg from Screening and More than 25mmHg | Eye disorders | — | — |
| Vitreous Hemorrhage | Eye disorders | — | — |
| Non-Ischemic Optic Neuropathy | Eye disorders | — | — |
| Retinal Detachment/Tear | Eye disorders | — | — |
| RETINAL VEIN OCCLUSION | Eye disorders | — | — |
| Tilt & decentration requiring SSI | Eye disorders | — | — |
| Corneal Edema | Eye disorders | — | — |
| Iritis | Eye disorders | — | — |
| Difficulty Breathing | Respiratory, thoracic and mediastinal disorders | — | — |
| Cancer | General disorders | — | — |
| Wrist Fracture Surgery | Surgical and medical procedures | — | — |
| Pneumonia/COVID-19 | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Higher Cylinder Group | Lower Cylinder Group |
|---|---|---|---|
| Undesirable Optical Phenomena | Eye disorders | — | — |
Most-reported serious reactions: Cystoid Macular Edema, Elevated IOP requiring treatment, Lens Axis Misalignment requiring SSI, Hospitalization, IOP Elevated Without Need for Treatment, Undesirable Optical Phenomena, Visual Symptoms requiring SSI, IOP Greater than 10mmHg from Screening and More than 25mmHg.
Data from ClinicalTrials.gov NCT03791619 adverse events section.
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03791619.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing