Evaluation of Quality of Vision and Spectacle Independence With the AcrySof® Panoptix® Intraocular Lens

Cataract Clinical Trial

Official title:

Evaluation of Quality of Vision and Spectacle Independence With Bilateral Implantation of the AcrySof® Panoptix® Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124952
• Other study ID #: AS-19-001
• Status: Completed
• Start date: October 3, 2019
• Est. completion date: February 16, 2021

Study information

• Verified date: August 2021
• Source: SightTrust Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a study to assess the spectacle independence and quality of vision of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Description:

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option

• Gender: Males and Females.

• Age: 40 or older.

• Willing and able to provide written informed consent for participation in the study.

• Willing and able to comply with scheduled visits and other study procedures.

• Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)

• Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens.

• Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Irregular astigmatism (e.g. keratoconus)

• Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)

• Monocular status (e.g. amblyopia)

• Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)

• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)

• Diabetic retinopathy

• Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)

• History of retinal detachment

• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.

• Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Panoptix
Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)

Locations

Country	Name	City	State
United States	SightTrust Eye Institute	Sunrise	Florida

Sponsors (2)

Lead Sponsor	Collaborator
SightTrust Eye Institute	Science in Vision

Country where clinical trial is conducted

United States, 

References & Publications (2)

McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26. — View Citation

Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Emmetropic Subjects Who Are Spectacle Independent	Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and = 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time").	3 months
Secondary	Binocular Uncorrected Distance Visual Acuity	Binocular logMAR uncorrected distance visual acuity	3 months
Secondary	Binocular Uncorrected Intermediate Visual Acuity	Binocular logMAR uncorrected intermediate visual acuity	3 months
Secondary	Binocular Uncorrected Near Visual Acuity	Binocular logMAR uncorrected near visual acuity	3 months
Secondary	Binocular Corrected Distance Visual Acuity	Binocular logMAR corrected distance visual acuity	3 months
Secondary	Binocular Distance-corrected Intermediate Visual Acuity	Binocular distance-corrected intermediate visual acuity in logMAR	3 months
Secondary	Binocular Distance-corrected Near Visual Acuity	Binocular logMAR distance-corrected near visual acuity	3 months
Secondary	Spherical Equivalent Refraction	Spherical equivalent refraction in diopters	3 months
Secondary	Residual Refractive Cylinder	Residual refractive cylinder in diopters	3 months
Secondary	Quality of Vision Questionnaire	Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better.	3 months
Secondary	Overall Spectacle Independence	percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - "a little of the time" or "none of the time")	3 months