Status:
UNKNOWN
Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
Lead Sponsor:
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
Conditions:
Cataract
Eligibility:
All Genders
22+ years
Phase:
NA
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 ...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05186298
Start Date
November 2 2021
End Date
May 1 2022
Last Update
January 11 2022
Active Locations (5)
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1
Eye Care Now
Panama City, Florida, United States, 32405
2
Seeta Eye Center
Poughkeepsie, New York, United States, 12603
3
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
4
Lehmann Eye Center
Nacogdoches, Texas, United States, 75965