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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

1 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

Primary outcomes

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 outcomes

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".

Sponsors and collaborators

Lead sponsor

MDbackline, LLC

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Oct 19, 2015
Registry last updated: Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed