Astigmatism Clinical Trial
Official title:
Clinical Results With the AcrySof Toric Intraocular Lens (IOL)
| NCT number | NCT01214863 |
| Other study ID # | M07-007 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | August 7, 2008 |
| Last updated | September 27, 2012 |
| Start date | August 2007 |
| Verified date | October 2010 |
| Source | Alcon Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator Exclusion Criteria: - Ocular comorbidities affecting visual outcome data, - Prior refractive surgery, - Irregular astigmatism |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Alcon Call Center for Trial Locations | Fort Worth | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Alcon Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Acuity | 1 day to 6 months | No | |
| Secondary | Postoperative refractive cylinder | 1day to 6 months | No |
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