NCT02649842

Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)

Completed NA Results posted Last updated 4 February 2025

What this trial tests

NA trial testing TECNIS Toric Models ZCT450, ZCT525 or ZCT600 in Cataract in 101 participants. Completed in 28 January 2019.

Timeline

21 March 2016

Primary endpoint
27 August 2018

28 January 2019

Quick facts

Lead sponsor	Abbott Medical Optics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	101
Start date	21 March 2016
Primary completion	27 August 2018
Estimated completion	28 January 2019

Drugs / interventions tested

• TECNIS Toric Models ZCT450, ZCT525 or ZCT600

Conditions studied

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

Sponsor

Abbott Medical Optics

Who can join

22 and older, any sex, with Cataract or 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.

Rate of Severe Visual Distortions Primary · 6 months

Rate of severe visual distortions based on data from a self administered subject questionnaire

Group	Value	95% CI
Extended Cylinder IOL	3

Rate of IOL Repositioning Due to IOL Misalignment Secondary · 6 months

Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL

Group	Value	95% CI
Extended Cylinder IOL	11

Percent Change in Cylinder Secondary · 6 months

Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))\*100

Group	Value	95% CI
Extended Cylinder IOL	88.36	± 21.09

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Extended Cylinder IOL

Serious: 19/101 (19%)

Deaths: 0/101

Serious adverse events (9 terms)

Reaction	System	Extended Cylinder IOL
Lens misalignment requiring IOL repositioning	Surgical and medical procedures	—
Hyphema	Eye disorders	—
Cystoid Macular Edema	Eye disorders	—
Hospitalization due to fall and broken hip	Injury, poisoning and procedural complications	—
Squamous Cell Carcinoma - Left second finger	Skin and subcutaneous tissue disorders	—
Hospitalization due to unsteady gait/dizziness	General disorders	—
Hospitalization due to appendectomy due to appendicitis	Surgical and medical procedures	—
Hospitalization due to motorcycle accident	Injury, poisoning and procedural complications	—
Lens exchange due to residual astigmatism and myopia	Surgical and medical procedures	—

Other adverse events (1 terms — click to expand)

Reaction	System	Extended Cylinder IOL
Iridocyclitis	Eye disorders	—

Most-reported serious reactions: Lens misalignment requiring IOL repositioning, Hyphema, Cystoid Macular Edema, Hospitalization due to fall and broken hip, Squamous Cell Carcinoma - Left second finger, Hospitalization due to unsteady gait/dizziness, Hospitalization due to appendectomy due to appendicitis, Hospitalization due to motorcycle accident.

Data from ClinicalTrials.gov NCT02649842 adverse events section.

Sponsor's own description

This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.

Publications & conference data

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