Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction	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".	At least 24 months after cataract surgery was performed. No upper limit on time since surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to drive without glasses	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".	At least 24 months after cataract surgery was performed. No upper limit on time since surgery.

Collaborators and Investigators

• Sponsor: MDbackline, LLC
• Investigators: Principal Investigator: John Hovanesian, MD, MDbackline, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 22, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: cataract satisfaction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: BAU141212