Outcomes of a Trifocal IOL in Post-refractive Patients

Study Overview
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Brief Summary
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To compare the prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.

Detailed Description
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The study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. All subjects will have previous LASIK and be at least 3 months post op PanOptix implantation. The study will enroll up to 200 patients and a statistical database will be created.

Official Title
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Outcomes of a Trifocal IOL in Post-refractive Patients

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: PanOptix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous myopic refractive surgery At least 3 months post op cataract surgery with a trifocal IOL Exclusion Criteria: Pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-refractive trifocal IOL<br> | Device: PanOptix<br>* Trifocal IOL with ORA in post refractive patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if preoperative IOL calculations or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery. | Percentage of eyes within +/- .5D of target for each formula and ORA. Overall % of eyes that have a disagreement between the two methods | Pre-op to 9 month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative monocular visual acuity | Monocular Uncorrected Distance, Intermediate, Near Visual Acuity | 3 to 9 month visit | 
| Post-operative best corrected visual acuity | Manifest refraction, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, and Near Visual Acuity | 3 to 9 month visit | 
| Post-operative uncorrected visual acuity | Binocular Uncorrected Distance, Intermediate, Near Visual Acuity, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, Near Visual Acuity | 3 to 9 month visit | 
| Post-operative visual acuity | Percentage of eyes with Uncorrected Distance Visual Acuity of 20/20 or better, 20/25 or better, and 20/30 or better | 3 to 9 month visit | 
| Post-operative visual acuity | Percentage of eyes with Uncorrected Corrected Intermediate Visual Acuity and Distance Corrected Intermediate Visual Acuity 20/20 or better, 20/25 or better, and 20/30 or better | 3 to 9 month visit | 
| Post-operative visual acuity | Percentage of eyes with Uncorrected Distance Near Visual Acuity and Distance Corrected Near Visual Acuity of 20/20 or better, 20/25 or better, and 20/30 or better | 3 to 9 month visit | 
| Patient's quality of vision and reported side-effects | Patient satisfaction questionnaire | 3 to 9 month visit |