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

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Status: Unknown

Conditions: Cataract

Treatments: Procedure: Cataract Surgery; Device: Synergy®; Device: AcrySof® IQ PanOptix®

Study type: Interventional

Funder types: Other

Identifiers

NCT05186298

68985013

Details and patient eligibility

About

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.

Full description

Eligible test subjects will be patients diagnosed with cataracts bilaterally who are interested and eligible for implantation of a presbyopia-correcting multifocal intraocular lenses.

Subjects will participate in ten study visits. Visits will include a screening visit (both eyes evaluated), one operative visit for each eye, and 7 postoperative visits. Both eyes will be implanted, with the second eye surgery occurring X (depends on the patient and the schedule) days after the first.

Enrollment: 320 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups

AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX)

Experimental group

Description:

The subject will be implanted bilaterally during cataract surgery

Treatment:

Procedure: Cataract Surgery

Device: AcrySof® IQ PanOptix®

Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA)

Experimental group

Description:

The subject will be implanted bilaterally during cataract surgery

Treatment:

Procedure: Cataract Surgery

Device: Synergy®