Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

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Status

Completed

Conditions

Cataract

Treatments

Other: Survey

Study type

Observational

Funder types

Other

Identifiers

NCT02578524

BAU141212

Details and patient eligibility

About

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.

Full 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.

Enrollment

117 patients

Sex

All

Ages

1 to 99 years old

Volunteers

Accepts Healthy Volunteers

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