Recruiting

Bilateral Synergy & PanOptix

Sponsor:

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Code:

NCT05186298

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

AcrySof® IQ PanOptix®

Synergy®

Cataract Surgery

Study Details

Brief summary:

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.

Conditions

Cataract

Study ID

NCT05186298

Start date

Nov 2, 2021

Status verified date

Jan, 2022

Completion date

May, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

The subject will be implanted bilaterally during cataract surgery

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

The subject will be implanted bilaterally during cataract surgery

Interventions

AcrySof® IQ PanOptix®

The AcrySof IQ PanOptix® (Alcon) mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL

Synergy®

The TECNIS Synergy™ IOLs mitigate the effects of presbyopia by providing far vision comparable to an aspheric monofocal IOL. Compared to an aspheric monofocal IOL, the lens provides significantly improved intermediate and near vision, including in low-light conditions.

Cataract Surgery

IOL implantation will be performed

Primary outcome measure

  • Binocular DCNVA [ Time Frame: Up to Month 6 ]

Central Contacts and Locations

Central contacts

Satish S Modi, MD

845-454-1025smodieyes@aol.com

Sarah O Piza

845-454-1025sortiz523@aol.com

Locations

Eye Care Now

Recruiting

Panama City, Florida, United States, 32405

Contacts

Bret Fisher, M.D.

cmenck@eyecarenow.com

Principal Investigator:

Bret Fisher, M.D.

Seeta Eye Center

Recruiting

Poughkeepsie, New York, United States, 12603

Contacts

Satish S Modi, MD

spiza@seetaeye.com

Principal Investigator:

Satish S Modi, MD

Eye Care Specialists

Recruiting

Kingston, Pennsylvania, United States, 18704

Contacts

Richard Roth, D.O.

patti.myers@vipeyes.com

Principal Investigator:

Richard Roth, D.O.

Lehmann Eye Center

Recruiting

Nacogdoches, Texas, United States, 75965

Contacts

Robert Lehmann, M.D.

olucas@lehmanneyecenter.com

Principal Investigator:

Robert Lehmann, M.D.

Northwest Eye Surgeons

Recruiting

Seattle, Washington, United States, 98125

Contacts

Audrey T Rostov, M.D.

hannah.seo@nweyes.com

Principal Investigator:

Audrey T Rostov, M.D.

More Information

Sponsor

Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Last update posted

Jan 11, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons on 2022-01-11.