Overview

This trial is active, not recruiting.

Conditions cataract, astigmatism
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

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Eyes implanted with toric IOL
administration of patient self-assessment
Eyes implanted with non-toric IOL
administration of patient self-assessment

Primary Outcomes

Measure
Rate of reported visual distortion symptoms
time frame: Baseline and 1 week

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Abbott Medical Optics.