Panoptix Trifocal Lens in Post Refractive Myopic Laser Vision Correction Surgery
Status unconfirmed
Conditions studied: Cataract, Refractive Errors
In brief
The two main objectives of this study are to demonstrate safety and effectiveness of implanting the PanOptix Trifocal IOL in patients who have had previous myopic Lasik. The primary objectives to demonstrate clinical safety will be the quality of vision questionnaire (QUVID) which will demonstrate the patient's perception of halos, glares, and starbursts before and after the implantation of the trifocal IOL. The primary objective to demonstrate clinical effectiveness will be done by measuring visual outcomes at distance, intermediate, and near. In addition, the patients will also fill out the spectacle independence questionnaire (IOLSAT Questionnaire) to determine their level of glasses independence postoperatively. In addition, at the conclusion of the study the patient will also fill out a patient satisfaction survey.
Key facts
- Study ID
- NCT04698278
- Run by
- Parkhurst NuVision Clinical Research LLC
- People needed
- 20
- Starts
- 2021-03-08
- Expected to finish
- 2022-07-01
- Last updated by the study team
- 2021-03-17
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults, 22 years of age or older at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
- Previous myopic Lasik with a well centered optical zone, corneal higher-order aberrations less than 0.6 um for a 4 mm pupil (measured by iTrace), and a minimum keratometric reading of 35.0 D.
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
- Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.2 logMAR (Minimum Angle of Resolution) or better
- Calculated lens power within the available range
- Preoperative keratometric astigmatism at or less than 2.5 D in both operative eyes
- Clear intraocular media other than cataract in both eyes
You may not qualify if…
- Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema.
- Previous intraocular surgery other than myopic Lasik
- History of or current retinal conditions or predisposition to retinal conditions
- Amblyopia
- Rubella, congenital, traumatic, or complicated cataracts
- History of or current anterior or posterior segment inflammation of any etiology
- Iris neovascularization
- Glaucoma (uncontrolled or controlled with medication)
- Optic nerve atrophy
- Subjects with diagnosed degenerative eye disorders
- Pregnancy or lactation
- Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative BCDVA to a level worse than 0.30 logMAR.
Where it is running
- Parkhurst NuVision — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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