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

Not Applicable

• Conditions: Cataract

• Registration Number: NCT05186298
• Lead Sponsor: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

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.

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 Timeline

• Study Start: 2021-11-02
• Study First Submitted: 2021-11-16
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Eye Care Now; 🇺🇸 Panama City, Florida, United States

Seeta Eye Center; 🇺🇸 Poughkeepsie, New York, United States

Eye Care Specialists; 🇺🇸 Kingston, Pennsylvania, United States

Lehmann Eye Center; 🇺🇸 Nacogdoches, Texas, United States

Northwest Eye Surgeons; 🇺🇸 Seattle, Washington, United States