Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population

Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04528069

Enrollment

Registered

2020-08-27

Start date

2020-11-16

Completion date

2021-12-17

Last updated

2022-12-30

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

Conditions

Aphakia, Corneal Astigmatism

Keywords

Intraocular lens, Cataract

Brief summary

The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.

Detailed description

Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye. Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months. This study will be conducted in Australia.

Interventions

DEVICEACRYSOF® IQ PanOptix® Toric Trifocal IOL

Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia.

PROCEDURECataract surgery

Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60); * Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes; * Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes; * Other protocol-defined inclusion criteria may apply. Key

Exclusion criteria

* Preoperative irregular astigmatism; * Clinically significant corneal abnormalities; * Glaucoma; * History of or current retinal disease; anterior or posterior segment inflammation; * Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK); * Other protocol-defined

Design outcomes

Primary

Measure	Time frame	Description
Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined	Month 3 postoperative, Month 6 postoperative	Manifest cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Residual manifest cylinder was measured in diopters and reported in plus cylinder form, with a smaller number indicating a lesser amount of added correction. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure.
Percentage of Eyes With IOL Rotation Less Than 10 Degrees	Month 3 postoperative, Month 6 postoperative	IOL rotation was defined as the difference in IOL axis of orientation from Day 1 postoperative. IOL rotation was assessed by the investigator using a slit lamp and was recorded in degrees, with a smaller number indicating less rotation. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure.
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)	Month 3 postoperative, Month 6 postoperative	Visual acuity (VA) was assessed at a distance of 4 meters with refractive correction in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure.
Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)	Month 3 postoperative, Month 6 postoperative	Visual acuity (VA) was assessed at a distance of 60 meters with distance correction (plus or minus power) in place. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure.
Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)	Month 3 postoperative, Month 6 postoperative	Visual acuity (VA) was assessed at a distance of 40 centimeters with distance correction (plus or minus power) in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure.
Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category	Up to Month 6 postoperative	A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. SSIs are reported categorically as SSIs related to the IOL and due to optical properties, SSIs related to the IOL and not due to optical properties, and SSIs unrelated to the IOL.
Percentage of Subjects With a Severe Visual Disturbance	Preoperative, Month 3 postoperative, Month 6 postoperative	The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding Yes were then asked to rate how severe their worst experience was during the past 7 days. Subjects responded on a 5-point scale: 0=None; 1=A little; 2=Mild; 3=Moderate; 4=Severe. Subjects responding No were automatically imputed as reporting, 0=None. Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure.
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)	Preoperative, Month 3 postoperative, Month 6 postoperative	QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding Yes were then asked to rate how severe their worst experience was with the vision-related experience in the past 7 days. Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Subjects responding No were automatically imputed as reporting, 0=Not bothered at all. Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure.
Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects	Up to Month 6 postoperative	An adverse event (AE) was defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure.
Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects	Up to Month 6 postoperative	An adverse event (AE) was defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure.

Countries

Australia

Participant flow

Recruitment details

Subjects were recruited from 4 investigative sites located in Australia.

Pre-assignment details

A total of 58 subjects were enrolled in the study (i.e., signed informed consent), of whom 4 were screen failures. This reporting group includes all subjects (54) implanted with the IOL in one or both eyes.

Participants by arm

Arm	Count
PanOptix Toric Trifocal IOL PanOptix Toric Trifocal intraocular lens (IOL) implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes were implanted (bilateral implantation).	54
Total	54

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Lost to Follow-up	1
Overall Study	Patient Unable to Attend	1
Overall Study	Patient Unable to Come	1

Baseline characteristics

Characteristic	PanOptix Toric Trifocal IOL
Age, Continuous	66.8 years STANDARD_DEVIATION 9.99
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants
Race/Ethnicity, Customized Asian	54 Participants
Race/Ethnicity, Customized Black or African American	0 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants
Race/Ethnicity, Customized Other	0 Participants
Race/Ethnicity, Customized White	0 Participants
Region of Enrollment Australia	54 participants
Sex: Female, Male Female	36 Participants
Sex: Female, Male Male	18 Participants
Specific Asian Nationality Chinese	54 Participants
Specific Asian Nationality Japanese	0 Participants
Specific Asian Nationality Korean	0 Participants
Specific Asian Nationality Mongolian	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 54	0 / 54	0 / 51	0 / 54
other Total, other adverse events	0 / 54	5 / 54	4 / 51	0 / 54
serious Total, serious adverse events	0 / 54	1 / 54	1 / 51	1 / 54

Outcome results

Primary

Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)

Visual acuity (VA) was assessed at a distance of 4 meters with refractive correction in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure.