Cataract
Conditions
Keywords
Cataract
Brief summary
To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.
Interventions
DEVICEAcrySof® Toric intraocular lens
Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Monolateral or bilateral cataracts * anticipated intraocular lens (IOL) power of +10 Diopters (D) \ +25D * 0.75 \ 2.0 D of astigmatism measured preoperatively by Keratometry readings * able to sign the informed consent, to comply with scheduled visits and other study procedures
Exclusion criteria
* Preoperative ocular pathology * previous intraocular or corneal surgery * an increased risk for complications which could require vitreoretinal surgery * corneal irregularities * corneal opacities * current contact lens usage * uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotational Stability | 6 Months post-surgery | Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Refractive Cylinder | 6 Months post-surgery | The refractive astigmatism 6 months post-surgery, measured in diopters. |
Countries
United States
Participant flow
Recruitment details
79 eyes of 71 patients were enrolled into the study. 10 eyes (6 patients) were excluded from analysis for astigmatic keratomy outside of the protocol requirements
Pre-assignment details
non-randomized
Participants by arm
| Arm | Count |
|---|---|
| Toric Implantation with the AcrySof® Toric intraocular lens | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | Toric |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 33 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
Rotational Stability
Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Time frame: 6 Months post-surgery
Population: 67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toric | Rotational Stability | 4 degrees | Standard Error 3 |
Secondary
Residual Refractive Cylinder
The refractive astigmatism 6 months post-surgery, measured in diopters.
Time frame: 6 Months post-surgery
Population: 69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toric | Residual Refractive Cylinder | 0.4 diopters | Standard Error 0.4 |