Patient Perception of Visual Distortions
This trial is active, not recruiting.
|Treatment||administration of patient self-assessment|
|Sponsor||Abbott Medical Optics|
|Start date||August 2014|
|End date||October 2014|
|Trial size||80 participants|
|Trial identifier||NCT02203747, TIOL-201-VPAS|
The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.
|Observational model||case control|
Eyes implanted with toric IOL
Eyes implanted with non-toric IOL
Rate of reported visual distortion symptoms
time frame: Baseline and 1 week
Male or female participants at least 22 years old.
Inclusion Criteria: - Corneal astigmatism of at least 0.75 diopters - Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes - At least one month postoperative from second-eye surgery - Ability to understand, read and write English to give consent and complete study questionnaire - Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits - Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization - Other protocol-defined inclusion criteria may apply Exclusion Criteria: - Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms - Patient is pregnant or is lactating - Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial - Other protocol-defined exclusion criteria may apply
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