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Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

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Alcon

Status

Completed

Conditions

Cataract

Treatments

Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02529488
ILH297-P002

Details and patient eligibility

About

The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

Full description

This study will be conducted in regions where the test article is approved at the time of study start.

Enrollment

167 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
  • Clear intraocular media other than cataract in both eyes;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
  • Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
  • Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
  • Pregnant or lactating;
  • Expected to require ocular surgical or retinal laser treatment;
  • Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

167 participants in 1 patient group

TFNT00
Experimental group
Description:
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Treatment:
Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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