Patient Perception of Visual Distortions

Abbott

Status: Completed

Conditions: Cataract; Astigmatism

Treatments: Other: Administration of patient self-assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT02203747

TIOL-201-VPAS

Details and patient eligibility

About

The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.

Enrollment: 79 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

79 participants in 2 patient groups

Pseudophakic implanted with toric IOL

Description:

Subjects bilaterally implanted with toric IOL

Treatment:

Other: Administration of patient self-assessment

Pseudophakic implanted with non-toric IOL

Description:

Subjects bilaterally implanted with non-toric IOL

Treatment:

Other: Administration of patient self-assessment