Clareon Toric vs Eyhance Toric

  • STATUS
    Recruiting
  • days left to enroll
    84
  • participants needed
    185
  • sponsor
    Alcon Research
Updated on 27 October 2022
astigmatism
intraocular lens implantation
bilateral cataracts
phacoemulsification
presbyopia
alcon

Summary

The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative.

Description

This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits.

Details
Condition Cataract, Aphakia
Treatment Eyhance IOL, Clareon IOL, Clareon Toric IOL, Eyhance Toric IOL, Phacoemulsification surgery
Clinical Study IdentifierNCT05481125
SponsorAlcon Research
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Planned bilateral cataract removal by routine small incision phacoemulsification surgery
Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism
Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator
Other protocol-specified inclusion criteria may apply

Exclusion Criteria

Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce the potential BCDVA to a level worse than 0.2 logMAR
Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome
History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK))
Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame
Other protocol-specified exclusion criteria may apply
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