Panoptix Trifocal Lens in Post Refractive Myopic Laser Vision Correction Surgery

NCT04698278 | Unknown FDA Device

• 1 other identifier: TFL210
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The two main objectives of this study are to demonstrate safety and effectiveness of implanting the PanOptix Trifocal IOL in patients who have had previous myopic Lasik. The primary objectives to demonstrate clinical safety will be the quality of vision questionnaire (QUVID) which will demonstrate the patient's perception of halos, glares, and starbursts before and after the implantation of the trifocal IOL. The primary objective to demonstrate clinical effectiveness will be done by measuring visual outcomes at distance, intermediate, and near. In addition, the patients will also fill out the spectacle independence questionnaire (IOLSAT Questionnaire) to determine their level of glasses independence postoperatively. In addition, at the conclusion of the study the patient will also fill out a patient satisfaction survey.

Conditions

Cataract; Refractive Errors

Outcome Measures

Primary Outcomes (8)

• Quality of vision questionnaire (QUVID)

  Will assess patient complaints of glares, halos and starbursts after implantation of the trifocal PanOptix lens. Each of these three symptoms will be assessed on how often they occur, severity of each symptom, and how bothersome they are for the patient. The patient will rank the how often they occur as never, rarely, sometimes, most of the time, and always. The patient will rank severity of their worst experience as: none, a little, mild, moderate, and severe. And the patient will rank how bothered they are by each of these symptoms as: not bothered at all, bothered a little bit, bothered somewhat, bothered quite a bit, or bothered very much.

  3 months post surgery

• Quality of vision questionnaire (QUVID)

  Will assess patient complaints of glares, halos and starbursts after implantation of the trifocal PanOptix lens. Each of these three symptoms will be assessed on how often they occur, severity of each symptom, and how bothersome they are for the patient. The patient will rank the how often they occur as never, rarely, sometimes, most of the time, and always. The patient will rank severity of their worst experience as: none, a little, mild, moderate, and severe. And the patient will rank how bothered they are by each of these symptoms as: not bothered at all, bothered a little bit, bothered somewhat, bothered quite a bit, or bothered very much.

  6 months post surgery

• Patient Vision Satisfaction Survey

  Will look at the level of patient satisfaction with their overall visual quality. Patient will be asked to grade their visual satisfaction as being very satisfied, satisfied, neither satisfied nor dissatisfied, or dissatisfied.

  3 months post surgery

• Patient Vision Satisfaction Survey

  Will look at the level of patient satisfaction with their overall visual quality. Patient will be asked to grade their visual satisfaction as being very satisfied, satisfied, neither satisfied nor dissatisfied, or dissatisfied.

  6 months post surgery

• Spectacle Independence Questionnaire (IOLSAT Questionnaire)

  Will look at the level of spectacle independence in patients who receive the trifocal PanOptix IOL for their cataracts. Patients will be asked how often they need to wear glasses for near, intermediate, and distant activities in both dim and bright lighting conditions. These will be graded as rarely, sometimes, most of the time, and all the time. Patients will also be asked to characterize their overall visual quality without glasses at near, intermediate, and distant activities in dim and bright lighting conditions. Patients will rank these as: very poor, poor, fair, good, or very good.

  3 months post surgery

• Spectacle Independence Questionnaire (IOLSAT Questionnaire)

  Will look at the level of spectacle independence in patients who receive the trifocal PanOptix IOL for their cataracts. Patients will be asked how often they need to wear glasses for near, intermediate, and distant activities in both dim and bright lighting conditions. These will be graded as rarely, sometimes, most of the time, and all the time. Patients will also be asked to characterize their overall visual quality without glasses at near, intermediate, and distant activities in dim and bright lighting conditions. Patients will rank these as: very poor, poor, fair, good, or very good.

  6 months post surgery

• Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).

  Will assess vision at these 3 focal points

  3 months post surgery

• Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).

  Will assess vision at these 3 focal points

  6 months post surgery

Study Arms (1)

Surgical Treatment Group

This is a prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had prior myopic Lasik and will receive a PanOptix Trifocal IOL in both eyes at the time of cataract surgery. These patients will then be followed for up to 6-months to assess their refractive predictability, quality of vision, spectacle independence, and overall patient satisfaction.

Device: PanOptix Trifocal Intraocular Lens

Interventions

PanOptix Trifocal Intraocular Lens DEVICE

This is a FDA approved trifocal lens that will be placed in patients who have had previous myopic LASIK or PRK.

Surgical Treatment Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bilateral cataracts in individuals who have had prior myopic laser assisted in situ keratomileusis or photorefractive keratectomy. Topography ablation patterns need to be well centered, and the corneal higher order aberration number needs to be less than 0.6 um for a 4 mm pupillary diameter on the itrace. PanOptix IOL power will be selected by utilizing the American Society of Cataract and Refractive Surgery online post refractive calculator: https://iolcalc.ascrs.org/. In addition, this IOL power calculation will be confirmed with Alcon's intraoperative ORA aberrometer.

You may qualify if:

• Adults, 22 years of age or older at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
• Previous myopic Lasik with a well centered optical zone, corneal higher-order aberrations less than 0.6 um for a 4 mm pupil (measured by iTrace), and a minimum keratometric reading of 35.0 D.
• Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
• Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.2 logMAR (Minimum Angle of Resolution) or better
• Calculated lens power within the available range
• Preoperative keratometric astigmatism at or less than 2.5 D in both operative eyes
• Clear intraocular media other than cataract in both eyes

You may not qualify if:

• Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema.
• Previous intraocular surgery other than myopic Lasik
• History of or current retinal conditions or predisposition to retinal conditions
• Amblyopia
• Rubella, congenital, traumatic, or complicated cataracts
• History of or current anterior or posterior segment inflammation of any etiology
• Iris neovascularization
• Glaucoma (uncontrolled or controlled with medication)
• Optic nerve atrophy
• Subjects with diagnosed degenerative eye disorders
• Pregnancy or lactation
• Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative BCDVA to a level worse than 0.30 logMAR.

Sponsors & Collaborators

• Parkhurst NuVision Clinical Research LLC: lead
• Alcon Research: collaborator

Study Sites (1)

Parkhurst NuVision

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Cataract; Refractive Errors

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Brett H Mueller, D.O., Ph.D.

CONTACT

2105852020; bmueller@nuvisiontx.com

Greg Parkhurst, M.D.

CONTACT

2105852020; gparkhurst@nuvisiontx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 6, 2021
• Study Start: March 8, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (1)