Patient Perception of Visual Distortions

Abbott Medical Optics1 site in 1 country79 target enrollmentAugust 2014

ConditionsCataract Astigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Abbott Medical Optics
Enrollment: 79
Locations: 1
Primary Endpoint: Visual Distortion Symptoms
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

January 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Optics

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Visual Distortion Symptoms

Time Frame: 1 week

Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.