Patient Perception of Visual Distortions

Completed

• Conditions: Cataract; Astigmatism
• Interventions: Other: Administration of patient self-assessment

• Registration Number: NCT02203747
• Lead Sponsor: Abbott Medical Optics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Study Start: 2014-08
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2015-09
• Results First Submitted: 2015-09-30
• Results First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Results First Posted: 2015-12-22
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pseudophakic implanted with non-toric IOL	Administration of patient self-assessment	Subjects bilaterally implanted with non-toric IOL
Pseudophakic implanted with toric IOL	Administration of patient self-assessment	Subjects bilaterally implanted with toric IOL

Primary Outcome Measures

Name	Time	Method
Visual Distortion Symptoms	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.

Trial Locations

Locations (1)

Contact AMO for Trial Locations; 🇺🇸 Santa Ana, California, United States