Ignite Creation Date:
2025-12-18 @ 8:12 AM
Ignite Modification Date:
2025-12-23 @ 9:03 PM
Study NCT ID:
NCT02578524
Status:
None
Last Update Posted:
2015-10-26 00:00:00
First Post:
2015-10-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
Sponsor:
None
Organization:
Study Overview
Official Title:
Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
Status:
None
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: