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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04545073
Other study ID # IOL-VTV-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 9, 2020
Est. completion date May 2021

Study information

Verified date October 2020
Source Vance Thompson Vision ND
Contact Sarah Thiede
Phone 7015665390
Email sarah.thiede@vancethompsonvision.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 2021
Est. primary completion date March 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
PanOptix
Trifocal IOL with ORA in post refractive patients

Locations

Country Name City State
United States Vance Thompson Vision ND W. Fargo North Dakota

Sponsors (1)

Lead Sponsor Collaborator
Vance Thompson Vision ND

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Post-operative monocular visual acuity Monocular Uncorrected Distance, Intermediate, Near Visual Acuity 3 to 9 month visit
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Patient's quality of vision and reported side-effects Patient satisfaction questionnaire 3 to 9 month visit
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