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Patient Perception of Visual Distortions

NCT ID: NCT02203747

Last Updated: 2015-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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Conditions

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Cataract Astigmatism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pseudophakic implanted with toric IOL

Subjects bilaterally implanted with toric IOL

Administration of patient self-assessment

Intervention Type OTHER

Pseudophakic implanted with non-toric IOL

Subjects bilaterally implanted with non-toric IOL

Administration of patient self-assessment

Intervention Type OTHER

Interventions

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Administration of patient self-assessment

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Medical Optics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact AMO for Trial Locations

Santa Ana, California, United States

Site Status

Countries

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United States

Other Identifiers

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TIOL-201-VPAS

Identifier Type: -

Identifier Source: org_study_id