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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014