An interventional study of AcrySof IQ PanOptix Presbyopia Correcting IOL and Cataract surgery in Aphakia and Presbyopia, sponsored by Alcon Research. Completed at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
Among 23 studies in Aphakia by Alcon Research — 2 open to participants now, 3 under way, none of them phase 3. Aphakia · Alcon Research.
Among the 23 studies in Aphakia by Alcon Research, this one is the 8th largest by enrollment of the 21 interventional ones, is one of 2 that started in 2021, is one of 21 with no phase, and was the 7th registered.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 181 is above the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →2 of the 23 studies in Aphakia by Alcon Research are open now, in 4 countries. Each count lists the studies.
Of the 6 Aphakia studies recruiting now, 4 (67%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2021.
Median enrollment 129 across the 21 interventional studies, 614 across the 2 observational. Of the 18 that completed or were terminated, 11 (61%) have results posted.
Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
1 of the studies in Aphakia by Alcon Research that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07587138Alcon ResearchClinical Evaluation of a Novel Trifocal IOL | 2027-07 |
Among the 23 studies in Aphakia by Alcon Research, from their registry updates:
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
Device: AcrySof IQ PanOptix Presbyopia Correcting IOL · Procedure: Cataract surgery
UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China.
Also known as: Model TFNT00
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular
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.
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Number of Ocular Treatment Emergent Adverse Events
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.
Time frame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Number of Non-Ocular Treatment Emergent Adverse Events
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.
Time frame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Number of Secondary Surgical Interventions
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.
Time frame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
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.
Time frame: 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)
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
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 Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint.
Time frame: 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)
Participants were recruited from 9 investigative sites located in China.
| Milestone | PanOptix IOL |
|---|---|
| Started | 144 |
| Attempted implantation, first eye | 144 |
| Attempted implantation second eye | 142 |
| Successful implantation, first eye | 144 |
| Successful implantation second eye | 142 |
| Completed | 134 |
| Not completed | 10 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 5 |
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.
| percentage of eyes | PanOptix IOL - First Eye | PanOptix IOL - Second Eye | PanOptix IOL - All Eyes |
|---|---|---|---|
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular | 100 | 98.5 | 99.3 |
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.
| percentage of participants | PanOptix IOL |
|---|---|
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular | 100 |
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.
| logMAR | PanOptix IOL - First Eye | PanOptix IOL - Second Eye | PanOptix IOL - All Eyes |
|---|---|---|---|
| Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular | -0.02 ± 0.102 | -0.02 ± 0.119 | -0.02 ± 0.110 |
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.
| logMAR | PanOptix IOL |
|---|---|
| Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular | -0.08 ± 0.102 |
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.
| logMAR | PanOptix IOL - First Eye | PanOptix IOL - Second Eye | PanOptix IOL - All Eyes |
|---|---|---|---|
| Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular | 0.073 ± 0.1110 | 0.072 ± 0.1329 | 0.073 ± 0.1222 |
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.
| logMAR | PanOptix IOL |
|---|---|
| Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular | 0.018 ± 0.0875 |
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.
| logMAR | PanOptix IOL - First Eye | PanOptix IOL - Second Eye | PanOptix IOL - All Eyes |
|---|---|---|---|
| Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular | 0.082 ± 0.1074 | 0.078 ± 0.1175 | 0.080 ± 0.1124 |
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.
| logMAR | PanOptix IOL |
|---|---|
| Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular | 0.025 ± 0.0865 |
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.
| adverse events | PanOptix IOL - First Eye | PanOptix IOL - Second Eye | PanOptix IOL - All Eyes |
|---|---|---|---|
| Number of Ocular Treatment Emergent Adverse Events | 37 | 33 | 70 |
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.
| adverse events | Pan Optix IOL |
|---|---|
| Number of Non-Ocular Treatment Emergent Adverse Events | 28 |
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.
| secondary surgical interventions | PanOptix IOL - First Eye | PanOptix IOL - Second Eye | PanOptix IOL - All Eyes |
|---|---|---|---|
| Number of Secondary Surgical Interventions | 0 | 0 | 0 |
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.
| participants | Month 6 Post Second Eye Implantation | Month 12 Post Second Eye Implantation |
|---|---|---|
| Starbursts | 13 | 21 |
| Halos | 9 | 6 |
| Glare | 6 | 3 |
| Hazy Vision | 3 | 1 |
| Blurred Vision | 3 | 2 |
| Double Vision | 0 | 0 |
| Dark Area | 0 | 0 |
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 Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint.
| participants | Month 6 Post Second Eye Implantation | Month 12 Post Second Eye Implantation |
|---|---|---|
| Starbursts | 2 | 2 |
| Halos | 3 | 2 |
| Glare | 4 | 2 |
| Hazy Vision | 0 | 0 |
| Blurred Vision | 1 | 1 |
| Double Vision | 0 | 0 |
| Dark Area | 0 | 0 |
Collected over Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/144 (0%) | 0/144 (0%) | 2/144 (1.4%) |
| PanOptix IOL Ocular - First Eye | 0/144 (0%) | 2/144 (1.4%) | 15/144 (10.4%) |
| PanOptix IOL Ocular - Second Eye | 0/142 (0%) | 3/142 (2.1%) | 11/142 (7.7%) |
| PanOptix IOL Systemic | 0/144 (0%) | 6/144 (4.2%) | 0/144 (0%) |
| Event | Pretreatment | PanOptix IOL Ocular - First Eye | PanOptix IOL Ocular - Second Eye | PanOptix IOL Systemic |
|---|---|---|---|---|
| Cystoid macular oedemaEye disorders | 0/144 | 2/144 | 3/142 | 0/144 |
| Coronary artery diseaseCardiac disorders | 0/144 | 0/144 | 0/142 | 1/144 |
| DeafnessEar and labyrinth disorders | 0/144 | 0/144 | 0/142 | 1/144 |
| Inguinal herniaGastrointestinal disorders | 0/144 | 0/144 | 0/142 | 1/144 |
| Neck painMusculoskeletal and connective tissue disorders | 0/144 | 0/144 | 0/142 | 1/144 |
| Cerebral infarctionNervous system disorders | 0/144 | 0/144 | 0/142 | 1/144 |
| Renal cystRenal and urinary disorders | 0/144 | 0/144 | 0/142 | 1/144 |
| Event | Pretreatment | PanOptix IOL Ocular - First Eye | PanOptix IOL Ocular - Second Eye | PanOptix IOL Systemic |
|---|---|---|---|---|
| Dry eyeEye disorders | 2/144 | 15/144 | 11/142 | 0/144 |
Full Analysis Set: This analysis population includes all subjects who had successful IOL implantation in at least one eye and at least one postoperative effectiveness assessment.
| Age, Continuous(years) | PanOptix IOL |
|---|---|
| Mean | 64.4 ± 9.19 |
| Age, Customized(Participants) | PanOptix IOL |
|---|---|
| Less than 65 years | 72 |
| 65 years and older | 72 |
| Sex: Female, Male(Participants) | PanOptix IOL |
|---|---|
| Female | 90 |
| Male | 54 |
| Race/Ethnicity, Customized(Participants) | PanOptix IOL |
|---|---|
| Chinese/Asian | 144 |
| Region of Enrollment(Participants) | PanOptix IOL |
|---|---|
| China | 144 |
PDFs hosted by the registry, ClinicalTrials.gov.
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