Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

NCT ID: NCT02578524

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-10-31

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.

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.

Conditions

Cataract

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Accommodating Lenses

Patients who underwent surgery with an accommodating lens implant.

Survey

Intervention Type: OTHER

Multifocal Lenses

Patients who underwent surgery with an multifocal lens implant.

Survey

Intervention Type: OTHER

Interventions

Survey

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with uncomplicated bilateral cataract surgery with either multifocal or accommodating lens implants performed at least 24 months previously

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MDbackline, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Hovanesian, MD

Role: PRINCIPAL_INVESTIGATOR

MDbackline, LLC

Locations

Harvard Eye Associates

Laguna Hills, California, United States

Countries

United States

Other Identifiers

BAU141212

Identifier Type: -

Identifier Source: org_study_id