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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: AcrySof® IQ PanOptix®; Procedure: Cataract Surgery; Device: Synergy®

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Satish S Modi, MD; Phone Number: 845-454-1025; Email: smodieyes@aol.com
• Study Contact Backup: Name: Sarah O Piza; Phone Number: 845-454-1025; Email: sortiz523@aol.com

Study Locations

• United States
  • Florida
    • Panama City, Florida, United States, 32405
      • Recruiting
      • Eye Care Now
      • Contact: Bret Fisher, M.D.; Email: cmenck@eyecarenow.com
      • Principal Investigator: Bret Fisher, M.D.
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Recruiting
      • Seeta Eye center
      • Contact: Satish S Modi, MD; Email: spiza@seetaeye.com
      • Principal Investigator: Satish S Modi, MD
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Recruiting
      • Eye Care Specialists
      • Contact: Richard Roth, D.O.; Email: patti.myers@vipeyes.com
      • Principal Investigator: Richard Roth, D.O.
  • Texas
    • Nacogdoches, Texas, United States, 75965
      • Recruiting
      • Lehmann Eye Center
      • Contact: Robert Lehmann, M.D.; Email: olucas@lehmanneyecenter.com
      • Principal Investigator: Robert Lehmann, M.D.
  • Washington
    • Seattle, Washington, United States, 98125
      • Recruiting
      • Northwest Eye Surgeons
      • Contact: Audrey T Rostov, M.D.; Email: hannah.seo@nweyes.com
      • Principal Investigator: Audrey T Rostov, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX); The subject will be implanted bilaterally during cataract surgery	Device: 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; Procedure: Cataract Surgery; IOL implantation will be performed
Experimental: Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA); The subject will be implanted bilaterally during cataract surgery	Procedure: Cataract Surgery; IOL implantation will be performed; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular DCNVA	Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm	Up to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Disturbances Evaluation	Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits	at all visits
Visual Disturbances Evaluation by Questionnaire (QUVID)	Patient reported visual disturbances by questionnaire (QUVID) postop	Up to Month 6
BCDVA and DCIVA (60 cm)	Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured	Up to Month 6
DCNVA (40 cm)	Monocular DCNVA (40 cm) in both groups will be measured	Up to Month 6
Uncorrected Monocular and Binocular VA	Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm)	Up to Month 6
Visual Disturbances Evaluation by Questionnaire (IOL SAT)	Patient satisfaction of each group by questionnaire (IOL SAT) postop	Up to Month 6
Defocus Curve	Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D)	Up to Month 6

Collaborators and Investigators

• Sponsor: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
• Investigators: Principal Investigator: Satish S Modi, MD, Seeta Eye Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 68985013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No