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NCT02566083

Post-Approval Study of the Tecnis® Toric IOL

Completed NA Results posted Last updated 18 January 2020
What this trial tests

NA trial testing non-toric intraocular lens in Cataract in 365 participants. Completed in 23 May 2019.

Timeline
21 October 2015
Primary endpoint
11 December 2018
23 May 2019

Quick facts

Lead sponsorAbbott Medical Optics
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment365
Start date21 October 2015
Primary completion11 December 2018
Estimated completion23 May 2019
Sites44 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Abbott Medical Optics

Who can join

22 and older, any sex, with Cataract. 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

The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.

GroupValue95% CI
Toric IOL189
Non-toric IOL142
Toric IOL0
Non-toric IOL2

Adverse events — posted to ClinicalTrials.gov

Time frame: All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Toric IOL
Serious: 32/214 (15%)
Deaths: 1/214
Non-toric IOL
Serious: 16/151 (11%)
Deaths: 2/151

Serious adverse events (19 terms)

ReactionSystemToric IOLNon-toric IOL
Lens repositioningSurgical and medical procedures——
HospitalizationGeneral disorders——
Cystoid Macular EdemaEye disorders——
Elevated intraocular pressure requiring treatmentEye disorders——
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
DeathGeneral disorders——
Epiretinal membrane with significant Vitreo-Retinal tractionEye disorders——
Macular HoleEye disorders——
Clinically Significant Macular EdemaEye disorders——
Residual Cortical materialSurgical and medical procedures——
Capsular RuptureEye disorders——
Retinal DetachmentEye disorders——
HyphemaEye disorders——
Macular EdemaEye disorders——
Capsular TearEye disorders——
Vitreous StrandEye disorders——
Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Crerebrovascular AccidentVascular disorders——
Ulcerative ColitisGastrointestinal disorders——
Other adverse events (1 terms — click to expand)

ReactionSystemToric IOLNon-toric IOL
Cystoid Macular EdemaEye disorders——

Most-reported serious reactions: Lens repositioning, Hospitalization, Cystoid Macular Edema, Elevated intraocular pressure requiring treatment, Breast Cancer, Death, Epiretinal membrane with significant Vitreo-Retinal traction, Macular Hole.

Data from ClinicalTrials.gov NCT02566083 adverse events section.

Sponsor's own description

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference

Publications & conference data

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

Verify or expand the search:

Other recruiting trials for Cataract

Currently open trials in the same condition.

Other Abbott Medical Optics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02566083.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing