Outcomes of a Trifocal IOL in Post-refractive Patients

Refractive Errors Clinical Trial

— TrIPLe  

Official title:

Outcomes of a Trifocal IOL in Post-refractive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04545073
• Other study ID #: IOL-VTV-01
• Status: Recruiting
• 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
• 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.)

Related Conditions & MeSH terms

• Refractive Errors

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