Patient Perception of Visual Quality and Function

Completed

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

• Registration Number: NCT02146599
• Lead Sponsor: Abbott Medical Optics

Brief Summary

The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-07-07
• Results First Submitted QC: 2015-08-10
• Status Verified: 2015-09
• Results First Posted: 2015-09-07
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Minimum 22 years of age
• Pseudophakic patients who have been bilaterally implanted with the same type of intraocular lenses in both eyes
• Ability to understand, read and write English to give consent and complete the study questionnaires
• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
• Other protocol-defined inclusion criteria might apply

Exclusion Criteria

• Any ocular pathology of clinical significance, as determined by the investigator, that may affect visual outcomes or influence subjective ocular/visual symptoms
• Patient is pregnant or is lactating
• Concurrent participation or participation within 30 days prior in any other clinical trial
• Other protocol-defined exclusion criteria might apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pseudophakic	Administration of patient self-assessment	-

Primary Outcome Measures

Name	Time	Method
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery	Baseline and 1 week	Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.

Trial Locations

Locations (1)

Daniel Chang, M.D.; 🇺🇸 Bakersfield, California, United States