Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02578524|
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : October 26, 2015
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Actual Enrollment :||117 participants|
|Observational Model:||Case Control|
|Official Title:||Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Patients who underwent surgery with an accommodating lens implant.
Patients who underwent surgery with an multifocal lens implant.
- Satisfaction [ Time Frame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery. ]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".
- Ability to drive without glasses [ Time Frame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery. ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578524
|United States, California|
|Harvard Eye Associates|
|Laguna Hills, California, United States, 92653|
|Principal Investigator:||John Hovanesian, MD||MDbackline, LLC|