Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

Cataract Clinical Trial

Official title:

Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578524
• Other study ID #: BAU141212
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: October 22, 2015
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: MDbackline, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 99 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• Survey

Locations

Country	Name	City	State
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
MDbackline, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction	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".	At least 24 months after cataract surgery was performed. No upper limit on time since surgery.	No
Secondary	Ability to drive without glasses	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".	At least 24 months after cataract surgery was performed. No upper limit on time since surgery.	No