Outcomes of a Trifocal IOL in Post-refractive Patients

• Conditions: Refractive Errors
• Interventions: Device: PanOptix

• Registration Number: NCT04545073
• Lead Sponsor: Vance Thompson Vision ND

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-10
• Status Verified: 2020-10
• Study Start: 2020-10-09
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-refractive trifocal IOL	PanOptix	-

Primary Outcome Measures

Name	Time	Method
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.	Pre-op to 9 month visit	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

Secondary Outcome Measures

Name	Time	Method
Post-operative monocular visual acuity	3 to 9 month visit	Monocular Uncorrected Distance, Intermediate, Near Visual Acuity
Post-operative best corrected visual acuity	3 to 9 month visit	Manifest refraction, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, and Near Visual Acuity
Post-operative visual acuity	3 to 9 month visit	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
Post-operative uncorrected visual acuity	3 to 9 month visit	Binocular Uncorrected Distance, Intermediate, Near Visual Acuity, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, Near Visual Acuity
Patient's quality of vision and reported side-effects	3 to 9 month visit	Patient satisfaction questionnaire

Trial Locations

Locations (1)

Vance Thompson Vision ND; 🇺🇸 W. Fargo, North Dakota, United States