NCT04755231

Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population

Completed NA Results posted Last updated 10 October 2023

What this trial tests

NA trial testing AcrySof IQ PanOptix Presbyopia Correcting IOL in Aphakia in 181 participants. Completed in 15 March 2023.

Timeline

19 April 2021

Primary endpoint
31 August 2022

15 March 2023

Quick facts

Lead sponsor	Alcon Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	181
Start date	19 April 2021
Primary completion	31 August 2022
Estimated completion	15 March 2023
Sites	9 locations across China

Drugs / interventions tested

• AcrySof IQ PanOptix Presbyopia Correcting IOL
• Cataract surgery — full drug profile →

Conditions studied

• Aphakia — all drugs for Aphakia →
• Presbyopia — all drugs for Presbyopia →

Sponsor

Alcon Research — full company profile →

Who can join

18 and older, any sex, with Aphakia or Presbyopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL - First Eye	100
PanOptix IOL - Second Eye	98.5
PanOptix IOL - All Eyes	99.3

Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL	100

Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL - First Eye	-0.02	± 0.102
PanOptix IOL - Second Eye	-0.02	± 0.119
PanOptix IOL - All Eyes	-0.02	± 0.110

Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL	-0.08	± 0.102

Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL - First Eye	0.073	± 0.1110
PanOptix IOL - Second Eye	0.072	± 0.1329
PanOptix IOL - All Eyes	0.073	± 0.1222

Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL	0.018	± 0.0875

Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL - First Eye	0.082	± 0.1074
PanOptix IOL - Second Eye	0.078	± 0.1175
PanOptix IOL - All Eyes	0.080	± 0.1124

Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL	0.025	± 0.0865

Number of Ocular Treatment Emergent Adverse Events Primary · Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL - First Eye	37
PanOptix IOL - Second Eye	33
PanOptix IOL - All Eyes	70

Number of Non-Ocular Treatment Emergent Adverse Events Primary · Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
Pan Optix IOL	28

Number of Secondary Surgical Interventions Primary · Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. Posterior capsulotomies were excluded from the definition of secondary surgical interventions. No hypothesis testing was pre-specified for this endpoint.

Group	Value	95% CI
PanOptix IOL - First Eye	0
PanOptix IOL - Second Eye	0
PanOptix IOL - All Eyes	0

Number of Participants Reporting a Severe Visual Disturbance (QUVID) Primary · Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Severe Was Your Worst Experience" and responded on a 5-point scale, where 0-4 scale, where 0=none, 1=a little, 2=mild, 3=moderate, and 4=severe. No hypothesis testing was pre-specified for this endpoint.

Starbursts

Group	Value	95% CI
Month 6 Post Second Eye Implantation	13
Month 12 Post Second Eye Implantation	21

Halos

Group	Value	95% CI
Month 6 Post Second Eye Implantation	9
Month 12 Post Second Eye Implantation	6

Glare

Group	Value	95% CI
Month 6 Post Second Eye Implantation	6
Month 12 Post Second Eye Implantation	3

Hazy Vision

Group	Value	95% CI
Month 6 Post Second Eye Implantation	3
Month 12 Post Second Eye Implantation	1

Blurred Vision

Group	Value	95% CI
Month 6 Post Second Eye Implantation	3
Month 12 Post Second Eye Implantation	2

Double Vision

Group	Value	95% CI
Month 6 Post Second Eye Implantation	0
Month 12 Post Second Eye Implantation	0

Dark Area

Group	Value	95% CI
Month 6 Post Second Eye Implantation	0
Month 12 Post Second Eye Implantation	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pretreatment

Serious: 0/144 (0%)

Deaths: 0/144

PanOptix IOL Ocular - First Eye

Serious: 2/144 (1%)

Deaths: 0/144

PanOptix IOL Ocular - Second Eye

Serious: 3/142 (2%)

Deaths: 0/142

PanOptix IOL Systemic

Serious: 6/144 (4%)

Deaths: 0/144

Serious adverse events (7 terms)

Reaction	System	Pretreatment	PanOptix IOL Ocular - Firs…	PanOptix IOL Ocular - Seco…	PanOptix IOL Systemic
Cystoid macular oedema	Eye disorders	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Deafness	Ear and labyrinth disorders	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—
Renal cyst	Renal and urinary disorders	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Pretreatment	PanOptix IOL Ocular - Firs…	PanOptix IOL Ocular - Seco…	PanOptix IOL Systemic
Dry eye	Eye disorders	—	—	—	—

Most-reported serious reactions: Cystoid macular oedema, Coronary artery disease, Deafness, Inguinal hernia, Neck pain, Cerebral infarction, Renal cyst.

Data from ClinicalTrials.gov NCT04755231 adverse events section.

Sponsor's own description

The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A 12-Month Multicenter Postmarketing Clinical Study of a Trifocal Intraocular Lens in a Chinese Population.
   Liu X, Bao Y, Lu Y, Fan W, et al · · 2025 · PMID 41229554 · DOI 10.2147/opth.s541613