Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants

Status unconfirmed · Not applicable

Conditions studied: Cataract

In brief

The purpose of this study is to evaluate the AcrySof PanOptix Intraocular Lens (IOL) for binocular distance corrected near visual acuity (DCNVA) compared to TECNIS Synergy IOL. Presbyopia correcting diffractive intraocular implants (extended depth of focus, multifocal, and trifocal) provide cataract and refractive surgeons with an effective treatment means for allowing patients to experience increased spectacle independence post-cataract surgery.

Key facts

Study ID

NCT05186298

Run by

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

People needed

320

Starts

2021-11-02

Expected to finish

2022-05-01

Last updated by the study team

2022-01-11

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Note: Ocular criteria must be met in both eyes.
• are willing and able to understand and sign an informed consent;
• are willing and able to attend all study visits;
• Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted
• Clear intraocular media other than cataracts.
• Projected BCDVA of better than 0.10 logMAR.
• Preoperative regular keratometric astigmatism (by biometer) of less than or equal to 0.75D, in both eyes
• Biometer IOL calculations within +6.0 - +30.0 power range

You may not qualify if…

• If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
• Clinically significant corneal abnormality, irregularity, inflammation, or edema aberrations, corneal disease, degeneration, or conditions affecting postoperative visual acuity
• Glaucoma or Ocular Hypertension
• Planned multiple procedures (eg MIGS)
• Amblyopia, Strabismus
• Patient's IOL calculation that are outside the range of available lenses
• Prior corneal refractive surgery or other corneal surgery (e.g., corneal transplant, lamellar keratoplasty, LASIK, PRK)
• Previous anterior or posterior chamber surgery (e.g., vitrectomy) that the investigator feels may compromise visual outcomes
• Diabetic retinopathy if the investigator feels this will compromise visual outcomes
• Macular Pathology (i.e., ERM, ARMD, DMR etc.) if the investigator feels this will compromise visual outcomes
• History of retinal detachment
• If, in the surgeon's opinion, the subject is not an appropriate candidate for multifocal IOL implantation (eg. patients who are professional night drivers or pilots, and those with other occupations for whom induces dysphotopsias could put their career at risk)
• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.

Where it is running

• Eye Care Now — Panama City, Florida, United States (enrolling)
• Seeta Eye Center — Poughkeepsie, New York, United States (enrolling)
• Eye Care Specialists — Kingston, Pennsylvania, United States (enrolling)
• Lehmann Eye Center — Nacogdoches, Texas, United States (enrolling)
• Northwest Eye Surgeons — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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