Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:1 - 99
Updated:4/21/2016
Start Date:January 2015
End Date:October 2015

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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.

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.

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
We found this trial at
1
site
Laguna Hills, California 92653
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from
Laguna Hills, CA
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