Patient Perception of Visual Distortions

NCT02203747 | Completed Results

• 1 other identifier: TIOL-201-VPAS
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract; Astigmatism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

Administration of patient self-assessment OTHER

Pseudophakic implanted with non-toric IOL; Pseudophakic implanted with toric IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (1)

Contact AMO for Trial Locations

Santa Ana, California, 92705, United States

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Carrie Garufis
• Organization: Abbott Medical Optics

carrie.garufis@abbott.com

714-566-3728

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 30, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: December 22, 2015
• Results First Posted: December 22, 2015

Record last verified: 2015-09

Locations

US (1)