Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon Pa… (NCT05518539) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
United States30 participantsStarted 2022-09-08
Plain-language summary
To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
* Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a trifocal IOL
* Meet the requirements for on-label implantation of the trifocal IOL
* Gender: Males and Females.
* Age: 40 or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract).
* Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
* All eyes will be in the range of availability for Clareon PanOptix IOL and Clareon PanOptix Toric IOL. For cylinder below the Toric IOL indication (T3), an LRI will be used during surgery.
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.
* Patients with any corneal pathology (including corneal dystrophies, scaring, severe dry eye syndrome, irregular astigmatism, HOA) limiting or affecting visual potential.
* Patients with previous corneal refractive surgery.
* Patients with pre-existing ocular pathology, including maculopathy, ARMD, ERM, prior RD, and glaucoma limiting or affecting visual potential.
* Subjects who…
What they're measuring
1
Binocular Distance-corrected Near (40 cm) Visual Acuity
Timeframe: 1 month postoperatively
2
Binocular Distance-corrected Near (40 cm) Visual Acuity