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| Name | Class |
|---|---|
| Johnson & Johnson Surgical Vision, Inc. | INDUSTRY |
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The goal of this clinical investigation is to evaluate visual acuity and contrast sensitivity in low lighting conditions using several different testing devices, and measure nighttime side effects of intraocular lens (IOL) implants after cataract surgery.
Researchers will compare the results for three different types of IOLs to see how each lens contributes to overall visual function, patient experience and satisfaction.
Participants will:
The purpose of the study is to correlate the low contrast defocus curves, objective halometry measurement of low light photic phenomena, and patient reported dysphotopsia profiles of the various study IOLs.
The primary endpoints are low (50%) contrast defocus curve, halometry (cool white light) assessment of photic phenomena, and PRVSQv2 results.
The secondary endpoints are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecnis Monofocals | Pseudophakic subjects with Tecnis Monofocals, Models ZCB00, ZCUxxx, DIB00, GIB00, and DIUxxx intraocular lenses. |
| |
| Tecnis Symfony Optiblue | Pseudophakic subjects with Tecnis Symfony Optiblue, model ZXR00V, ZXWxxx intraocular lenses. |
| |
| Tecnis Odyssey | Pseudophakic subjects with Tecnis Odyssey, model DRN00V, DRTxxx intraocular lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None-placebo | Other | No interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low (50%) contrast defocus curve | Measured low (50%) contrast defocus curve compared between all three groups | Day 1 |
| Halometry assessment of photic phenomena | Halometry assessment of halos and starbursts utilizing a cool white light with varying intensities. Comparing the measured size of the ring (deg) of each condition between all three groups. | Day 1 |
| PRVSQv2 questionnaire results | PRVSQv2 questionnaire results compared between all three groups: Frequency and bother/severity of symptoms (scale 1 to 5, with 5 most bothersome) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected distance visual acuity (BCDVA) | Best corrected distance visual acuity (BCDVA) compared between all three groups | Day 1 |
| Low contrast (50%) BCDVA | Low contrast (50%) BCDVA compared between all three groups |
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Inclusion Criteria:
Exclusion Criteria:
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Bilateral pseudophakia, at least 3 months postoperative from IOL implantation with one of the study IOL models.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittany M Camirand | Contact | 661-301-6211 | bcamirand@empireeyeandlaser.com | |
| Daniel H Chang, MD | Contact | 661-325-3937 | dchang@empireeyeandlaser.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel H Chang, MD | Empire Eye and Laser Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye and Laser Center | Recruiting | Bakersfield | California | 93309 | United States |
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| Day 1 |
| Contrast Sensitivity | Contrast sensitivity compared between all three groups | Day 1 |
| High Contrast Defocus Curve | High Contrast Defocus Curve compared between all three groups | Day 1 |
| Halometry | Halometry assessment of halos and starbursts utilizing various light colors (cool white, warm white, red, yellow, and green) and intensities. Comparing the measured size of the ring (deg) of each condition between all three groups. | Day 1 |
| Patient-Reported Outcome (PRO) Questionnaires | PRVSQv2 and AIOLIS vision questionnaire results compared between all three groups. Frequency and bother/severity of symptoms (scale 1 to 5, with 5 most bothersome) | Day 1 |
| Pupil Size | Photopic and mesopic pupil size compared between all three study groups | Day 1 |
| YAG Capsulotomies | Number of YAG capsulotomies performed within one year post-op compared between all three groups | Day 1 |
| Posterior capsular opacification (PCO) | Pre-planned post-hoc analysis evaluating number of participants with and without PCO compared between all three groups | Day 1 |
| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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