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OpenTrials
Completed

NCT Number: NCT02203747

Patient Perception of Visual Distortions

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

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Key information

Conditions

Cataract Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Contact AMO for Trial Locations

Santa Ana, California, 92705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of patient self-assessment

Other

Primary outcomes

  1. Visual Distortion Symptoms

    Time frame: Baseline

    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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 30, 2014
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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