Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses and Cataracts Surgery

Cataract Clinical Trial

Official title:

Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses Cataracts Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01946581
• Other study ID #: JH SAT 2013
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2013
• Last updated: September 16, 2013
• Start date: May 2013

Study information

• Verified date: September 2013
• Source: MDbackline, LLC
• Contact: Carol Hardy
• Phone: 949-900-5248
• Email: research[@]harvardeye.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction among patients who have recently undergone cataract surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with uncomplicated bilateral cataract surgery with a Tecnis Multifocal or monofocal implant completed at least 60 days before the survey date.

• Patient with and without astigmatic keratotomy will be included.

Exclusion Criteria:

• Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery

• Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)

• Patients with = grade 1 posterior capsule opacity at their last visit

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Cataract Surgery

Locations

Country	Name	City	State
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
MDbackline, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient overall satisfaction post Cataract surgery	Patient will be given a satisfaction survey based on overall satisfaction: Motivations for choosing their surgeon and for selecting an IOL choice; Fears that they had before surgery; Degree of spectacle independence for activities, including driving (day and night), watching television, computer use, reading print material, using their mobile phone; Degree of overall satisfaction with vision; Degree to which they notice unexpected side effects (dysphotopsias); Degree to which they felt informed about any side effects they did experience; Activities for which they would like to see better; Willingness to refer friends for the same surgery; Whether they have already referred friends for the same surgery	60 plus days Post surgery	No