Clinical trial NCT00344578: Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review
Official title: Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcomes Following Restor IOL Lens Implant
Keywords: Higher Order Abberations
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.

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, i.e. 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

Eligibility criteria: Inclusion Criteria:

All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.

Exclusion Criteria:

Patients who underwent conventional IOL cataract extraction surgery

Primary outcomes:
measure: 1)Visual acuity with and without correction of distance and near at 3-6 months
Secondary outcomes:
measure: Percent of patients requiring keratorefractive surgery
measure: Ocular comorbidity subgroup analysis
measure: Monocular implantation subanalysis (prior to LASIK)
measure: Comparison of post-op spherical equivalent to target refraction
measure: Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
measure: Subjective patient satisfaction
measure: Validated questionnaire assessing visual function and quality of life
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Aston Ambulatory Care Center
state: Texas
city: Dallas
country: United States
facility: UTSW Medical Center at Dallas
state: Texas
Study officials:
affiliation: UTSW Medical Center at Dallas
name: Adam Fedyk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UTSW Medical Center at Dallas
name: Vinod Mootha, MD
role: STUDY_DIRECTOR
affiliation: UTSW Medical Center at Dallas
name: James McCulley, MD
role: STUDY_CHAIR
References: