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Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02578524
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
MDbackline, LLC

Study Description
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Brief Summary:
This study will examine patient satisfaction and spectacle independence using a survey in patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens at least 2 years prior to administration of the survey.

Condition or disease Intervention/treatment
Cataract Other: Survey

Detailed Description:

Purpose: To compare patient-reported satisfaction with a multifocal vs an accommodating presbyopia-correcting at least two years following implantation of either type of implant.

Number of study subjects: 200 (half with multifocal and half with accommodating lens implants)

In this study, we will send a secure, online questionnaire to patients who have previously undergone cataract surgery at least two years previously. Patients will receive an email invitation, and by clicking the embedded link and verifying their identity with date of birth and phone number, they will be directed to a survey. The survey will ask the following types of questions:

  • overall satisfaction with the surgery
  • would they do the same surgery again?
  • would they choose the same (elective) lens implant again?
  • for what types of activities (reading newspaper, driving, driving at night, fine print) do they require glasses to see clearly?
  • do they experience glare and halo symptoms?
  • how bothered is the patient by these symptoms?

These data will be stored on a secure server. Statistical analysis will be done by a statistician, using a student's t-test to determine statistical significance of any difference between patients with different types of lens implants.

No intervention will be planned with patients, other than analyzing the survey results. All patient identifying (demographic) information will be carefully protected according to HIPAA and HITECH standards.

Study Design
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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort Intervention/treatment
Accommodating Lenses
Patients who underwent surgery with an accommodating lens implant.
 Other: Survey
Multifocal Lenses
Patients who underwent surgery with an multifocal lens implant.
 Other: Survey


Outcome Measures
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Primary Outcome Measures :
  1. Satisfaction [ Time Frame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery. ]
    The patients will be asked to rate their satisfaction with their surgical results on a scale of "very satisfied", "satisfied", "neither satisfied nor dissatisfied", "dissatisfied", or "very dissatisfied".


Secondary Outcome Measures :
  1. Ability to drive without glasses [ Time Frame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery. ]
    The patients will be asked to rate their ability to drive without glasses on a scale of "very satisfied", "satisfied", "neither satisfied nor dissatisfied", "dissatisfied", or "very dissatisfied".


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent cataract surgery with a multifocal or accommodating lens implant at least two years prior to the survey.
Criteria

Inclusion Criteria:

  • Patients with uncomplicated bilateral cataract surgery with either multifocal or accommodating lens implants performed at least 24 months previously
  • Patients with or without astigmatic keratotomy or other simultaneous procedures may be included, so long as exclusion criteria are not met.

Exclusion Criteria:

  • Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that, in the best judgment of the investigator, 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578524


Locations
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United States, California
Harvard Eye Associates
Laguna Hills, California, United States, 92653
Sponsors and Collaborators
MDbackline, LLC
Investigators
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Principal Investigator: John Hovanesian, MD MDbackline, LLC
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: MDbackline, LLC
ClinicalTrials.gov Identifier: NCT02578524    
Other Study ID Numbers: BAU141212
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015
Keywords provided by MDbackline, LLC:
cataract satisfaction
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases