Clinical Trials Directory

Trials / Completed

CompletedNCT02578524

Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
117 (actual)
Sponsor
MDbackline, LLC · Academic / Other
Sex
All
Age
1 Year – 99 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERSurvey

Timeline

Start date
2015-01-01
Primary completion
2015-10-01
Completion
2015-10-01
First posted
2015-10-19
Last updated
2015-10-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02578524. Inclusion in this directory is not an endorsement.