Cataract
Conditions
Keywords
Intraocular Lens (IOL)
Brief summary
The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be utilized to optimize the A-constant as well as manual subjective refraction (ie, to a clinically insignificant difference). The A-constant is the calculated number that helps the surgeon determine which IOL should be implanted in the eye during cataract surgery.
Detailed description
Subjects will be implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Standard clinical practice will be followed for pre-operative testing, IOL power estimation and IOL implantation. Only one eye will be enrolled in the study per surgeon determination. The eye will undergo both an automated and manual manifest refraction assessment at 3 months postoperative.
Interventions
PROCEDUREManifest refraction
Manifest refraction performed by autorefraction (automated) and manual procedures (standard)
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
DEVICETopcon® KR-1W Wave-Front Analyzer
Wavefront and topography system used to obtain autorefraction data
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent; * Willing and able to attend all scheduled study visits as required per protocol; * Diagnosed with cataract in one or both eyes; * Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed; * Preoperative keratometric astigmatism ≤ 1.0 diopter (D); * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential, pregnant, or breast-feeding; * History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol; * Previous intraocular or corneal surgery; * Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject; * Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOL A-constant at 3 Months at Each Site | Month 3 (Day 80-100) Post Study Eye Implantation | The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent. |
Participant flow
Recruitment details
Subjects were recruited from 3 investigative sites located in Ireland (1) and the US (2).
Pre-assignment details
Of the 162 enrolled, 12 subjects were exited as screen failures prior to intraocular lens (IOL) implantation. This reporting group includes all subjects with attempted implantation (150).
Participants by arm
| Arm | Count |
|---|---|
| Overall Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Subject moved too far away | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 7.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 9 / 150 | 0 / 150 |
| serious Total, serious adverse events | 4 / 150 | 2 / 150 |
Outcome results
Primary
IOL A-constant at 3 Months at Each Site
The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.
Time frame: Month 3 (Day 80-100) Post Study Eye Implantation
Population: All-Implanted Analysis Set with non-missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manifest Refraction | IOL A-constant at 3 Months at Each Site | Study Site 1 (US) | 119.23 unitless | Standard Deviation 0.408 |
| Manifest Refraction | IOL A-constant at 3 Months at Each Site | Study Site 2 (US) | 118.86 unitless | Standard Deviation 0.601 |
| Manifest Refraction | IOL A-constant at 3 Months at Each Site | Study Site 3 (Ireland) | 118.39 unitless | Standard Deviation 3.071 |
| Autorefraction | IOL A-constant at 3 Months at Each Site | Study Site 1 (US) | 119.18 unitless | Standard Deviation 0.493 |
| Autorefraction | IOL A-constant at 3 Months at Each Site | Study Site 2 (US) | 118.93 unitless | Standard Deviation 0.723 |
| Autorefraction | IOL A-constant at 3 Months at Each Site | Study Site 3 (Ireland) | 118.52 unitless | Standard Deviation 3.137 |
Comparison: To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction.90% CI: [-0.03, 0.13]
Comparison: To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction.90% CI: [-0.21, 0.07]
Comparison: To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction.90% CI: [-0.22, -0.04]