Outcomes of a Trifocal IOL in Post-refractive Patients (TrIPLe)

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.

Study Overview

• Status: Unknown
• Conditions: Refractive Errors
• Intervention / Treatment: Device: PanOptix

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Recruiting
      • Vance Thompson Vision ND
      • Contact: Sarah Thiede; Phone Number: 701-566-5390; Email: sarah.thiede@vancethompsonvision.com
      • Principal Investigator: Michael Greenwod, MD
      • Sub-Investigator: Nicholas Risbrudt, OD
      • Contact: Jake Hutchison; Phone Number: 701-566-5390; Email: jake.hutchison@vancethompsonvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-refractive trifocal IOL	Device: PanOptix; Trifocal IOL with ORA in post refractive patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vance Thompson Vision ND
• Investigators: Principal Investigator: Michael Greenwood, MD, Vance Thompson Vision ND

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: IOL-VTV-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No