Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

7 sites in 1 country.

About this study

Official title: Evaluation of Long-term Safety and Performance of AcrySof PanOptix Trifocal & PanOptix Trifocal Toric Intraocular Lens (IOL)

Conditions

Aphakia, Astigmatism, Presbyopia

Being tested

AcrySof IQ PanOptix IOL Toric, AcrySof IQ PanOptix IOL Non-Toric

Keywords

Cataract surgery

Medical subject headings

Aphakia, Astigmatism, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• AcrySof IQ PanOptix IOL ToricDevice

  Also called Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60

  Trifocal toric IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia who desire near, intermediate and distance vision with increased spectacle independence.

• AcrySof IQ PanOptix IOL Non-ToricDevice

  Also called Model TFNT00

  Trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism with and without presbyopia who desire near, intermediate and distance vision with increased spectacle independence.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)

   BCDVA was assessed for both eyes together at a distance of 4 meters using letter charts and recorded in logarithm of the minimum angle of resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL were categorized as toric as specified in the statistical analysis plan. No hypothesis testing was pre-specified for this endpoint.

   Measured: Year 3-5 postoperative (Visit 1, Day 1)

2. Number of Eyes Experiencing an Ocular Adverse Event by Toricity

   Ocular adverse events were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of ocular adverse events include the following:

   • Cystoid Macular Edema (CME)
   • Hypopyon
   • Endophthalmitis
   • Lens dislocation
   • Pupillary block
   • Retinal detachment
   • Secondary Surgical Interventions (explantation/exchange/repositioning) This outcome measure was pre-specified for eye-based reporting.

   Measured: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

3. Number of Subjects Experiencing a Non-Ocular Adverse Event

   AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative).

   Measured: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

4. Number of Device Deficiencies by Toricity

   Device deficiencies were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of device deficiencies include the following:

   • Failure to meet product specifications (e.g., incorrect IOL power)
   • IOL defect
   • Broken IOL optic
   • Broken IOL haptic
   • Scratched IOL optic
   • Unsealed device packaging
   • Suspected product contamination
   • Lack of performance This outcome measure was pre-specified for eye-based reporting.

   Measured: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 Dec 2023
2. Study start27 Apr 2024
3. Primary completion5 Feb 2025
4. Study completion5 Feb 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for AphakiaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.