Outcomes of a Trifocal IOL in Post-refractive Patients

NCT ID: NCT04545073

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-09

Study Completion Date

2021-05-31

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.

Conditions

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Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Post-refractive trifocal IOL

PanOptix

Intervention Type DEVICE

Trifocal IOL with ORA in post refractive patients

Interventions

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PanOptix

Trifocal IOL with ORA in post refractive patients

Intervention Type DEVICE

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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vance Thompson Vision ND

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Greenwood, MD

Role: PRINCIPAL_INVESTIGATOR

Vance Thompson Vision ND

Locations

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Vance Thompson Vision ND

West Fargo, North Dakota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Thiede

Role: CONTACT

7015665390

Facility Contacts

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Sarah Thiede

Role: primary

701-566-5390

Jake Hutchison

Role: backup

701-566-5390

Other Identifiers

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IOL-VTV-01

Identifier Type: -

Identifier Source: org_study_id

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