TrIPLe: Outcomes of a Trifocal IOL in Post-refractive Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Post-refractive trifocal IOL
|
Device: PanOptix
Trifocal IOL with ORA in post refractive patients
|
Outcome Measures
Primary Outcome Measures
- 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]
Percentage of eyes within +/- .5D of target for each formula and ORA. Overall % of eyes that have a disagreement between the two methods
Secondary Outcome Measures
- 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
- Post-operative visual acuity [3 to 9 month visit]
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
- Post-operative visual acuity [3 to 9 month visit]
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
- Patient's quality of vision and reported side-effects [3 to 9 month visit]
Patient satisfaction questionnaire
Eligibility Criteria
Criteria
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.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vance Thompson Vision ND | W. Fargo | North Dakota | United States | 58078 |
Sponsors and Collaborators
- Vance Thompson Vision ND
Investigators
- Principal Investigator: Michael Greenwood, MD, Vance Thompson Vision ND
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IOL-VTV-01