Patient Perception of Visual Distortions

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203747
• Other study ID #: TIOL-201-VPAS
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: November 18, 2015
• Start date: August 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2015
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Other:
• Administration of patient self-assessment

Locations

Country	Name	City	State
United States	Contact AMO for Trial Locations	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No