Clinical trial NCT05186298: Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
Official title: Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lead sponsor: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 320
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Binocular DCNVA
timeFrame: Up to Month 6
Secondary outcomes:
measure: Visual Disturbances Evaluation
timeFrame: at all visits
measure: Visual Disturbances Evaluation by Questionnaire (QUVID)
timeFrame: Up to Month 6
measure: BCDVA and DCIVA (60 cm)
timeFrame: Up to Month 6
measure: DCNVA (40 cm)
timeFrame: Up to Month 6
measure: Uncorrected Monocular and Binocular VA
timeFrame: Up to Month 6
measure: Visual Disturbances Evaluation by Questionnaire (IOL SAT)
timeFrame: Up to Month 6
measure: Defocus Curve
timeFrame: Up to Month 6
Other outcomes:
Locations:
city: Panama City
country: United States
facility: Eye Care Now
state: Florida
city: Poughkeepsie
country: United States
facility: Seeta Eye Center
state: New York
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
city: Seattle
country: United States
facility: Northwest Eye Surgeons
state: Washington
Study officials:
affiliation: Seeta Eye Centre
name: Satish S Modi, MD
role: PRINCIPAL_INVESTIGATOR
References: