NCT04210232

Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

Completed NA Results posted Last updated 12 October 2021

What this trial tests

NA trial testing TECNIS® TORIC II Intraocular Lens (IOL) in Cataract in 54 participants. Completed in 11 September 2020.

Timeline

14 January 2020

Primary endpoint
11 September 2020

11 September 2020

Quick facts

Lead sponsor	Johnson & Johnson Surgical Vision, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	14 January 2020
Primary completion	11 September 2020
Estimated completion	11 September 2020
Sites	12 locations across United States

Drugs / interventions tested

• TECNIS® TORIC II Intraocular Lens (IOL)

Conditions studied

• Cataract — all drugs for Cataract →
• Corneal Astigmatism — all drugs for Corneal Astigmatism →

Sponsor

Johnson & Johnson Surgical Vision, Inc. — full company profile →

Who can join

22 and older, any sex, with Cataract or Corneal Astigmatism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II Primary · 3 months postoperative

Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).

Very Satisfied/Satisfied

Group	Value	95% CI
TECNIS Toric II	100	95.8 – 100

Undecided/Dissatisfied/Very Dissatisfied

Group	Value	95% CI
TECNIS Toric II	0	0 – 4.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months postoperative. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TECNIS Toric II

Serious: 6/54 (11%)

Deaths: 0/54

Serious adverse events (6 terms)

Reaction	System	TECNIS Toric II
Hospitalization due to heart attack	Cardiac disorders	—
Hospitalization due to bleeding varices	Gastrointestinal disorders	—
Cystoid Macular Edema	Eye disorders	—
Hospitalization	Renal and urinary disorders	—
Hospitalization due to vomiting of blood	Gastrointestinal disorders	—
Hospitalization due to pneumonia	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Hospitalization due to heart attack, Hospitalization due to bleeding varices, Cystoid Macular Edema, Hospitalization, Hospitalization due to vomiting of blood, Hospitalization due to pneumonia.

Data from ClinicalTrials.gov NCT04210232 adverse events section.

Sponsor's own description

This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.