Aphakia, Astigmatism, Presbyopia
Conditions
Keywords
Cataract surgery
Brief summary
The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof IQ PanOptix IOL toric and non-toric models in subjects bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.
Detailed description
Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected at Visit 1, which will occur Year 3-5 postoperative.
Interventions
DEVICEAcrySof IQ PanOptix IOL Toric
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.
DEVICEAcrySof IQ PanOptix IOL Non-Toric
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.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or legally authorized representative must be able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form. * Subject must have had bilateral implantation of AcrySof PanOptix and/or AcrySof PanOptix Toric IOL models for 3 to 5 years prior to enrollment. A subject may have a toric lens in one eye and a non-toric in the fellow eye. * Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
Exclusion criteria
* Subject currently participating in another investigational drug or device study. * Subject has had corneal refractive surgery after AcrySof PanOptix or AcrySof PanOptix Toric IOL implantation. * Subject exposed to a study IOL for a minimum of 3 years prior to Visit 1 that have subsequently undergone an IOL exchange and are no longer implanted with a study IOL at the time of enrollment. * Subject is pregnant or nursing at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) | Year 3-5 postoperative (Visit 1, Day 1) | 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. |
| Number of Eyes Experiencing an Ocular Adverse Event by Toricity | Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1) | 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. |
| Number of Subjects Experiencing a Non-Ocular Adverse Event | Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1) | AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). |
| Number of Device Deficiencies by Toricity | Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1) | 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. |
Countries
Spain
Contacts
STUDY_DIRECTORClinical Trial Lead, Vision Care
Alcon Research
Participant flow
Recruitment details
Subjects were recruited from 7 investigative sites located in Spain.
Pre-assignment details
Of the 211 enrolled, 3 subjects were exited as screen failures. This reporting group includes all enrolled subjects who passed screening (Full Analysis Set). Note: 34 subjects were implanted with toric in one eye and non-toric in the other eye.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Equal to or greater than 65 years | 135 Participants |
| Age, Customized Less than 65 years | 73 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 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 | 104 Participants |
| Region of Enrollment Spain | 208 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 103 | 0 / 0 | 0 / 0 | 0 / 105 |
| other Total, other adverse events | 42 / 90 | 49 / 82 | 0 / 103 | 55 / 118 | 52 / 126 | 0 / 105 |
| serious Total, serious adverse events | 0 / 90 | 2 / 82 | 1 / 103 | 1 / 118 | 2 / 126 | 2 / 105 |
Outcome results
None listed