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

This study is currently recruiting participants.
Verified September 2013 by MDbackline, LLC
Sponsor:
Information provided by (Responsible Party):
MDbackline, LLC
ClinicalTrials.gov Identifier:
NCT01946581
First received: September 12, 2013
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Cataract
Procedure: Cataract Surgery

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses Cataracts Surgery

Resource links provided by NLM:


Further study details as provided by MDbackline, LLC:

Primary Outcome Measures:
  • Patient overall satisfaction post Cataract surgery [ Time Frame: 60 plus days Post surgery ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cataract Surgery Procedure: Cataract Surgery

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that have had Cataract Surgery.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946581

Contacts
Contact: Carol Hardy 949-900-5248 research@harvardeye.com

Locations
United States, California
Harvard Eye Associates Recruiting
Laguna Hills, California, United States, 92653
Principal Investigator: John Hovanesian, MD         
Sponsors and Collaborators
MDbackline, LLC
Investigators
Principal Investigator: John Hovanesian, MD MD backline
Study Director: John Hovanesian, MD MD Backline
  More Information

No publications provided

Responsible Party: MDbackline, LLC
ClinicalTrials.gov Identifier: NCT01946581     History of Changes
Other Study ID Numbers: JH SAT 2013
Study First Received: September 12, 2013
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014