Aphakia, Corneal Astigmatism
Conditions
Keywords
Cataract, Intraocular lens, Astigmatism, Toric
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.
Detailed description
Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period. This study will be conducted in Japan.
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
PROCEDURECataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye. * Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Irregular corneal astigmatism. * History of anterior segment, posterior segment, or optic nerve pathology. * History of previous intraocular or corneal (refractive or trauma related) surgery. * Any 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 |
|---|---|---|
| Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | Day 30-60 postoperative | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | Day 30-60 postoperative | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. |
| Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) | Day 30-60 postoperative | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 1 investigative site located in Japan.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| PanOptix Toric Trifocal IOL ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | PanOptix Toric Trifocal IOL |
|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 9.4 |
| Age, Customized 60-69 years | 10 participants |
| Age, Customized 70-79 years | 13 participants |
| Age, Customized 80 years and older | 1 participants |
| Age, Customized Less than 60 years | 8 participants |
| Race/Ethnicity, Customized Japanese | 32 participants |
| Region of Enrollment Japan | 32 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 7 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 / 32 | 0 / 32 | 0 / 9 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 5 / 32 | 1 / 9 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 9 | 0 / 32 |
Outcome results
Primary
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Time frame: Day 30-60 postoperative
Population: All Implanted Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PanOptix Toric Trifocal IOL | Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | 90.2 percentage of eyes |
p-value: <0.0001Exact Test of Binomial Proportion
Secondary
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Time frame: Day 30-60 postoperative
Population: All Implanted Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PanOptix Toric Trifocal IOL | Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) | 0.055 diopter | Standard Deviation 0.153 |
Secondary
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Time frame: Day 30-60 postoperative
Population: All Implanted Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PanOptix Toric Trifocal IOL | Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | 100 percentage of eyes |