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Outcomes of a Trifocal IOL in Post-refractive Patients (TrIPLe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545073
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Vance Thompson Vision ND

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
Refractive Errors Device: PanOptix

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Outcomes of a Trifocal IOL in Post-refractive Patients
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Post-refractive trifocal IOL Device: PanOptix
Trifocal IOL with ORA in post refractive patients




Primary Outcome Measures :
  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. [ Time Frame: Pre-op to 9 month visit ]
    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


Secondary Outcome Measures :
  1. Post-operative monocular visual acuity [ Time Frame: 3 to 9 month visit ]
    Monocular Uncorrected Distance, Intermediate, Near Visual Acuity

  2. Post-operative best corrected visual acuity [ Time Frame: 3 to 9 month visit ]
    Manifest refraction, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, and Near Visual Acuity

  3. Post-operative uncorrected visual acuity [ Time Frame: 3 to 9 month visit ]
    Binocular Uncorrected Distance, Intermediate, Near Visual Acuity, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, Near Visual Acuity

  4. Post-operative visual acuity [ Time Frame: 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

  5. Post-operative visual acuity [ Time Frame: 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

  6. Post-operative visual acuity [ Time Frame: 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

  7. Patient's quality of vision and reported side-effects [ Time Frame: 3 to 9 month visit ]
    Patient satisfaction questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545073


Contacts
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Contact: Sarah Thiede 7015665390 sarah.thiede@vancethompsonvision.com

Locations
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United States, North Dakota
Vance Thompson Vision ND Recruiting
W. Fargo, North Dakota, United States, 58078
Contact: Sarah Thiede    701-566-5390    sarah.thiede@vancethompsonvision.com   
Contact: Jake Hutchison    701-566-5390    jake.hutchison@vancethompsonvision.com   
Principal Investigator: Michael Greenwod, MD         
Sub-Investigator: Nicholas Risbrudt, OD         
Sponsors and Collaborators
Vance Thompson Vision ND
Investigators
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Principal Investigator: Michael Greenwood, MD Vance Thompson Vision ND
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Responsible Party: Vance Thompson Vision ND
ClinicalTrials.gov Identifier: NCT04545073    
Other Study ID Numbers: IOL-VTV-01
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases