Patient Perception of Visual Distortions

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

Study Overview

• Status: Completed
• Conditions: Cataract; Astigmatism
• Intervention / Treatment: Other: Administration of patient self-assessment

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Ana, California, United States, 92705
      • Contact AMO for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bilaterally-implanted pseudophakic subjects over 22 years of age with astigmatism who meet the inclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pseudophakic implanted with toric IOL; Subjects bilaterally implanted with toric IOL	Other: Administration of patient self-assessment
Pseudophakic implanted with non-toric IOL; Subjects bilaterally implanted with non-toric IOL	Other: Administration of patient self-assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Distortion Symptoms	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.	Baseline
Visual Distortion Symptoms	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.	1 week

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: TIOL-201-VPAS