Outcomes of a Trifocal IOL in Post-refractive Patients
TrIPLe
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedStudy Start
First participant enrolled
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedOctober 19, 2020
October 1, 2020
5 months
August 21, 2020
October 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Pre-op to 9 month visit
Secondary Outcomes (7)
Post-operative monocular visual acuity
3 to 9 month visit
Post-operative best corrected visual acuity
3 to 9 month visit
Post-operative uncorrected visual acuity
3 to 9 month visit
Post-operative visual acuity
3 to 9 month visit
Post-operative visual acuity
3 to 9 month visit
- +2 more secondary outcomes
Study Arms (1)
Post-refractive trifocal IOL
Interventions
Eligibility Criteria
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.
You may qualify if:
- Previous myopic refractive surgery
- At least 3 months post op cataract surgery with a trifocal IOL
You may not qualify if:
- Pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vance Thompson Vision ND
West Fargo, North Dakota, 58078, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Greenwood, MD
Vance Thompson Vision ND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
September 10, 2020
Study Start
October 9, 2020
Primary Completion
March 1, 2021
Study Completion
May 1, 2021
Last Updated
October 19, 2020
Record last verified: 2020-10