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

Cataract Clinical Trial

Official title:

Spectacle Independence and Overall Satisfaction With Bilateral Implantation of the AcrySof® Panoptix® Toric Intraocular Lens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04128514
• Other study ID #: BF-19-001
• Status: Terminated
• Start date: October 11, 2019
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2022
• Source: Eye Center of North Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• 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 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 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, 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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Panoptix Toric
Cataract surgery and IOL implantation

Locations

Country	Name	City	State
United States	Eye Center of North Florida	Panama City	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eye Center of North Florida	Science in Vision

Country where clinical trial is conducted

United States, 

References & Publications (2)

Akman A, Asena L, Ozturk C, Gür Güngör 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. — 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	Spectacle independence - emmetropia	Percent of patients with = 0.5D of refractive cylinder and = 0.50D of absolute residual spherical equivalent refraction postoperatively who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")	3 months
Secondary	Binocular uncorrected distance visual acuity	Binocular distance visual acuity	3 months
Secondary	Binocular uncorrected intermediate visual acuity	Binocular intermediate visual acuity	3 months
Secondary	BInocular uncorrected near visual acuity	Binocular near visual acuity	3 months
Secondary	Binocular best-corrected distance visual acuity	Binocular best-corrected distance visual acuity	3 months
Secondary	Binocular distance-corrected intermediate visual acuity	Binocular distance-corrected intermediate visual acuity	3 months
Secondary	Binocular distance-corrected near visual acuity	Binocular distance-corrected near visual acuity	3 months
Secondary	Spherical equivalent refraction	Spherical equivalent refraction	3 months
Secondary	Residual astigmatism	Residual astigmatism	3 months
Secondary	Uncorrected preferred reading distance	Uncorrected preferred reading distance	3 months
Secondary	Monocular corrected distance visual acuity	Monocular corrected distance visual acuity	3 months
Secondary	Spectacle independence - overall	Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")	3 months
Secondary	Binocular uncorrected visual acuity at preferred reading distance	Binocular uncorrected visual acuity at preferred reading distance	3 months
Secondary	VFQ-14	Questionnaire responses on VFQ-14 visual function questionnaire	3 months
Secondary	Choose lens again	Percent of patients who would choose this lens modality again.	3 months