Clinical trial NCT02578524: Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
Official title: Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract satisfaction
Lead sponsor: MDbackline, LLC
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 117
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent cataract surgery with a multifocal or accommodating lens implant at least two years prior to the survey.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction
timeFrame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.
Secondary outcomes:
measure: Ability to drive without glasses
timeFrame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
Study officials:
affiliation: MDbackline, LLC
name: John Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
References: