Clinical trial NCT04698278: Panoptix Trifocal Lens in Post Refractive Myopic Laser Vision Correction Surgery
Official title: Post-Approval Study of the Panoptix Trifocal Lens in Patients Who Have Had Post Refractive Myopic Laser Vision Correction Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Refractive Errors
Lead sponsor: Parkhurst NuVision Clinical Research LLC
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2021-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Clinical Hypothesis:

The rate of bothersome visual symptom items (defined as a very or extremely bothersome visual symptom that impacts daily living under overall condition) for the patients who are post-refractive who receive a PanOptix Trifocal IOL at the time of cataract surgery will be assessed. The bothersome visual symptom items of interest are halos, glare, and starbursts. Patients will also be assessed on level of glasses independence with an assessment of both corrected and uncorrected distance, intermediate, and near vision. Lastly patient satisfaction score will also be determined.

OVERALL STUDY DESIGN 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.

Duration:

6 months; however, any subject that undergoes a lens repositioning procedure due to IOL misalignment, or reports "very" or "extreme" overall bother that impacts daily living for any of the 3 defined bothersome visual symptoms (halos, glare, or starbursts) at 6 months, will be followed through 1 year postoperatively.

Administration:

Surgeons will perform routine small-incision, femtosecond laser assisted, cataract surgery and use the Alcon-recommended implantation systems for lens implantation. Refractive target outcomes will be emmetropia for both eyes.

Visit Schedule:

Subjects will be bilaterally implanted; the second eye is to be implanted within approximately one month after the first-eye surgery.

All subjects will undergo a minimum of 10 visits:

1. Preoperative for both eyes
2. Surgical Procedure for each individual eye
3. 1-day and 1-week visits for each eye
4. 1-month, 3-month, and 6-month visits for both eyes together
5. In addition, a 1-year postoperative visit will be required for subjects who undergo a lens repositioning procedure due to IOL misalignment at any time during the study, and for subjects who report "very" or "extreme" overall bother that impacts daily living for any of the 3 defined bothersome visual symptoms (halos, glare, or starbursts) at 6 months.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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.
3. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.2 logMAR (Minimum Angle of Resolution) or better
5. Calculated lens power within the available range
6. Preoperative keratometric astigmatism at or less than 2.5 D in both operative eyes
7. Clear intraocular media other than cataract in both eyes

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of vision questionnaire (QUVID)
timeFrame: 3 months post surgery
measure: Quality of vision questionnaire (QUVID)
timeFrame: 6 months post surgery
measure: Patient Vision Satisfaction Survey
timeFrame: 3 months post surgery
measure: Patient Vision Satisfaction Survey
timeFrame: 6 months post surgery
measure: Spectacle Independence Questionnaire (IOLSAT Questionnaire)
timeFrame: 3 months post surgery
measure: Spectacle Independence Questionnaire (IOLSAT Questionnaire)
timeFrame: 6 months post surgery
measure: Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).
timeFrame: 3 months post surgery
measure: Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).
timeFrame: 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
Study officials:
References: