Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344578
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2006-06-23
Brief Title:
Clinical Outcomes After AcrySof ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas A Retrospective Review
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Clinical Outcomes After AcrySof ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas A Retrospective Review
Status:
COMPLETED
Status Verified Date:
2006-06
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:
To evaluate the clinical outcomes of AcrySof ReSTOR IOL for the Faculty Practice at UTSW Medical Center at Dallas
Detailed Description:
The AcrySof ReSTOR intraocular lens IOL is the latest advance in vision surgery This IOL has been uniquely designed to improve vision throughout the entire visual spectrum up close far away and everything in-between Thus giving cataract patients their best chance ever to function free of glasses
The pre-operative and post-operative data from ReSTOR IOL implant cataract surgeries will be analyzed to determine whether the desired outcome was achieved ie excellent vision with no correction Variables to be studied include patient age gender number of ReSTOR IOL implants ocular comorbidities preoperative and postoperative corrected and uncorrected visual acuities keratometry readings and corneal topography readings A patient survey will also be sent to patients having undergone the surgery to measure their level of satisfaction
Project Goals The ultimate outcome of this project is to learn more insight on the following
1 Visual acuity with and without correction of distance and near at 3-6 months
2 Percent of patients requiring keratorefractive surgery
3 Ocular comorbidity subgroup analysis
4 Monocular implantation subanalysis prior to LASIK
5 Comparison of post-op spherical equivalent to target refraction
6 Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy
7 Subjective patient satisfaction
8 Validated questionnaire assessing visual function and quality of life
The pre-operative and post-operative data from ReSTOR IOL implant cataract surgeries will be analyzed to determine whether the desired outcome was achieved ie excellent vision with no correction Variables to be studied include patient age gender number of ReSTOR IOL implants ocular comorbidities preoperative and postoperative corrected and uncorrected visual acuities keratometry readings and corneal topography readings A patient survey will also be sent to patients having undergone the surgery to measure their level of satisfaction
Project Goals The ultimate outcome of this project is to learn more insight on the following
1 Visual acuity with and without correction of distance and near at 3-6 months
2 Percent of patients requiring keratorefractive surgery
3 Ocular comorbidity subgroup analysis
4 Monocular implantation subanalysis prior to LASIK
5 Comparison of post-op spherical equivalent to target refraction
6 Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy
7 Subjective patient satisfaction
8 Validated questionnaire assessing visual function and quality of life
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?:
None