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Assessment of an intraocular lens to provide independence from optical aids at all distances following cataract surgery in patients with astigmatism.

Investigation of AcrySof IQ Panoptix Presbyopia Correcting IOL for subjects with mild to moderate astigmatism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001109190
Enrollment
12
Registered
2019-08-12
Start date
2019-11-04
Completion date
2020-12-01
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Intraocular lens technology has significantly developed over time to include multifocal and trifocal options. The motivated patient can now readily achieve optical independence for most circumstances. Previously, Alcon have provided the Panoptix Presbyopia Correcting IOL in spherical form only. Residual astigmatism has been shown to decrease unaided visual acuity. As approximately 40% of patients will have corneal astigmatism of 0.75D or greater, this represents a significant cohort of patients that may not adequately benefit from the Panoptix IOL in its current format. (Teresa JCRS 2009) The introduction of a toric option presents a positive opportunity for these patients to optimize their unaided vision at all distances. The objective of this study is to describe the visual outcomes and safety at minimum 6 months (180 days) post bilateral implantation of the Panoptix Toric IOL. Subject information will be drawn from a single study visit however preoperative and prior surgical information will be collated also.

Interventions

This study is a prospective consecutive audit of effectiveness following cataract surgery or refractive lens exchange surgery in subjects with pre-existing astigmatism requiring trifocal toric IOL consideration. Patients who have previously undergone routine cataract and intraocular lens replacement with a Panoptix Trifocal Toric IOL will be identified. Patients at 6 months post procedure will be contacted about returning for a review visit (study visit). Participants will undertake a single

This study is a prospective consecutive audit of effectiveness following cataract surgery or refractive lens exchange surgery in subjects with pre-existing astigmatism requiring trifocal toric IOL consideration. Patients who have previously undergone routine cataract and intraocular lens replacement with a Panoptix Trifocal Toric IOL will be identified. Patients at 6 months post procedure will be contacted about returning for a review visit (study visit). Participants will undertake a single visit to confirm the visual acuity (distance, intermediate and near vision), refraction (prescription), defocus curve (best corrected vision at all distances), intraocular lens alignment and patient-reported outcome measurements (to measure vision-related quality of life). These tests will be undertaken by an experienced clinician with 20+ years in conducting ophthalmic examination and clinical trial assessments. The study requires attendance for a single study visit which is performed at least 6 months from the original uncomplicated procedure.

Sponsors

Alcon Laboratories
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. - are more than 40 years of age, of either gender and any race; - have completed uncomplicated cataract surgery or refractive lens exchange surgery with the Alcon Panoptix Toric IOL at least 6 months prior (but no greater than 12 months) - regular corneal astigmatism requiring toric IOL correction

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. - Amblyopia - Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) - Diabetic retinopathy - Macular degeneration - 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 post-operative visual acuity.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026