The purpose of the study is to evaluate the binocular clinical endpoints of distance, intermediate, and near vision and patient reported outcomes utilizing mini-monovision versus mix-match approaches for the correction of presbyopia with intraocular lenses.
Minimum 22 years of age
Bilateral cataracts for which posterior chamber IOL implantation has been planned
Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source
Potential for postoperative BCDVA of 20/30 Snellen or better
Requiring an intraocular lens power outside the available range of power
Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
Irregular corneal astigmatism
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
Parallel
TECNIS PureSee IOL (Model DEN00V/DET150)
DeviceBilateral implantation of the TECNIS PureSee intraocular lens following standard phacoemulsification cataract surgery. The non-dominant eye is intentionally targeted for a "second minus" near focus strategy (mini-monovision).
TECNIS PureSee IOL (Model DEN00V/DET150)
DeviceImplantation of the TECNIS PureSee intraocular lens into the dominant eye following standard phacoemulsification cataract surgery.
TECNIS Odyssey IOL (Model DRN00V/DRT150)
DeviceImplantation of the TECNIS Odyssey intraocular lens into the non-dominant eye following standard phacoemulsification cataract surgery.
Binocular UCDVA
Binocular Uncorrected Distance Visual Acuity
Binocular UCIVA
Binocular Uncorrected Intermediate Visual Acuity
Binocular UCNVA
Binocular Uncorrected Near Visual Acuity
Patient Reported Outcomes PRVSQv2
Patient Reported Outcomes (as recorded by the PRVSQ2 questionnaire). The questionnaire does not generate a scale-based or indexed score. Results are analyzed descriptively, capturing the frequency and distribution of specific visual complaints reported across the study population.
Patient Reported Outcomes PRSIQv2
Patient Reported Outcomes (as recorded by the PRSIQ2 questionnaire). The questionnaire does not generate a scale-based or indexed score. Results are analyzed descriptively, capturing the frequency and distribution of specific visual complaints reported across the study population.
Residual Refractive Error
Residual Refractive Error
Halometry
Dysphotopsias Measured by Clinical Halometry
Spectacle Use
Patient Reported Spectacle Use
Other Ocular/Visual Symptoms
Unsolicited visual or eye-related complaints volunteered by participants rather than specifically probed by the investigator. Serves as a secondary safety or tolerability measure to monitor unexpected sensory side effects. Quantified via non-leading, open-ended questioning during study visits or via non-directed adverse event logging
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Dr. Daniel H. Chang, MD
Lead sponsor
Empire Eye and Laser Center
Sponsor institution
Johnson & Johnson Surgical Vision, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
