NCT00762216CompletedNot Applicable
Rotational Stability of the AcrySof® Toric
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Rotational Stability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Toric
Other
Implantation with the AcrySof® Toric intraocular lens
Intervention: AcrySof® Toric intraocular lens (Device)
Outcomes
Primary Outcomes
Rotational Stability
Time Frame: 6 Months post-surgery
Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Secondary Outcomes
- Residual Refractive Cylinder(6 Months post-surgery)
Investigators
Study Sites (1)
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