Spectacle Independence and Overall Satisfaction With AcrySof® Panoptix® Toric Intraocular Lens

NCT ID: NCT04128514

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-11
• Study Completion Date: 2022-03-10

Brief Summary

The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric intraocular lens (IOL) after uneventful cataract surgery.

Detailed 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 and a quality of life questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Enrolled subjects

Subjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are appropriate candidates for multifocal lens implantation.

The Acrysof (R) Panoptix (R) Toric intraocular lens will be implanted in both eyes of subjects.

Panoptix Toric

Intervention Type: DEVICE

Cataract surgery and IOL implantation

Interventions

Panoptix Toric

Cataract surgery and IOL implantation

Intervention Type: DEVICE

Eligibility Criteria

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 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 toric IOL in the approved range (T3-T6) for the Panoptix lens.
• Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria

• Irregular astigmatism (e.g. keratoconus)
• Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
• Monocular status (e.g. amblyopia)
• Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
• Diabetic retinopathy
• Macular pathology (e.g. ARMD, ERM)
• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Science in Vision

OTHER

Sponsor Role: collaborator

Eye Center of North Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bret Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Center of North Florida

Locations

Eye Center of North Florida

Panama City, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28341605 (View on PubMed)

Akman A, Asena L, Ozturk C, Gur Gungor S. Evaluation of quality of life after implantation of a new trifocal intraocular lens. J Cataract Refract Surg. 2019 Feb;45(2):130-134. doi: 10.1016/j.jcrs.2018.12.003. Epub 2019 Jan 3.

Reference Type: BACKGROUND

PMID: 30612749 (View on PubMed)

Other Identifiers

BF-19-001

Identifier Type: -

Identifier Source: org_study_id