An observational study in Refractive Errors, sponsored by Vance Thompson Vision ND. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Vance Thompson Vision ND · Observational
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.
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.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 107 observational studies indexed under Refractive Errors.
Browse Refractive Errors studies →Vance Thompson Vision ND is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Charts from up to 200 myopic post-refractive patients who have received PanOptix will be reviewed at at least two Vance Thompson Vision sites (Fargo, ND and Sioux Falls, SD). All patients will have had ORA used during the cataract surgery.
Exclusion Criteria:
Device: PanOptix
Trifocal IOL with ORA in post refractive patients
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.
1. Percentage of eyes within +/- .5D of target for each formula and ORA. 2. Overall % of eyes that have a disagreement between the two methods
Time frame: Pre-op to 9 month visit
Post-operative monocular visual acuity
Monocular Uncorrected Distance, Intermediate, Near Visual Acuity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 to 9 month visit
Patient's quality of vision and reported side-effects
Patient satisfaction questionnaire
Time frame: 3 to 9 month visit
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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