Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery

NCT02578524 | Completed

• 1 other identifier: BAU141212
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

cataract satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Ability to drive without glasses

  At least 24 months after cataract surgery was performed. No upper limit on time since surgery.

Study Arms (2)

Accommodating Lenses

Patients who underwent surgery with an accommodating lens implant.

Other: Survey

Multifocal Lenses

Patients who underwent surgery with an multifocal lens implant.

Other: Survey

Interventions

Survey OTHER

Accommodating Lenses; Multifocal Lenses

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with uncomplicated bilateral cataract surgery with either multifocal or accommodating lens implants performed at least 24 months previously

You may not qualify if:

• 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

Sponsors & Collaborators

• MDbackline, LLC: lead

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• John Hovanesian, MD

  MDbackline, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 19, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

US (1)