Outcomes of a Trifocal IOL in Post-refractive Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04545073

Acronym

TrIPLe

Enrollment

200

Registered

2020-09-10

Start date

2020-10-09

Completion date

2021-05-31

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors

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.

Interventions

DEVICEPanOptix

Trifocal IOL with ORA in post refractive patients

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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
Post-operative visual acuity	3 to 9 month visit	Percentage of eyes with Uncorrected Distance Visual Acuity of 20/20 or better, 20/25 or better, and 20/30 or better
Patient's quality of vision and reported side-effects	3 to 9 month visit	Patient satisfaction questionnaire

Countries

United States

Contacts

Primary ContactSarah Thiede

sarah.thiede@vancethompsonvision.com7015665390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026