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OpenTrials
Completed

NCT Number: NCT00344578

Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review

To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aston Ambulatory Care Center, Dallas, Texas, United States

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About this study

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:

  • Visual acuity with and without correction of distance and near at 3-6 months
  • Percent of patients requiring keratorefractive surgery
  • Ocular comorbidity subgroup analysis
  • Monocular implantation subanalysis (prior to LASIK)
  • Comparison of post-op spherical equivalent to target refraction
  • Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
  • Subjective patient satisfaction
  • Validated questionnaire assessing visual function and quality of life

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restor IOL

Device

Primary outcomes

  1. 1)Visual acuity with and without correction of distance and near at 3-6 months

Secondary outcomes

  1. Percent of patients requiring keratorefractive surgery

  2. Ocular comorbidity subgroup analysis

  3. Monocular implantation subanalysis (prior to LASIK)

  4. Comparison of post-op spherical equivalent to target refraction

  5. Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?

  6. Subjective patient satisfaction

  7. Validated questionnaire assessing visual function and quality of life

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 27, 2006
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.