Multifocals and Accommodating/Bilateral Implantation of Different Multifocal Intraocular Lens (IOLs)

NCT00934960 | Terminated

• 1 other identifier: MRC 09-001
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate vision at different distances (far (13 ft), intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the patient wears them), range of vision (the difference between the farthest distance and the closest distance that the patient can comfortably read 20/25 of the near card), and patient satisfaction (how satisfied/happy is the patient with their vision) following bilateral implantation of different multifocal IOLs after routine phacoemulsification. The patients are being asked to participate in this study because you have had cataract surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval. This study is being conducted at Storm Eye Institute at the Medical University of South Carolina and will involve approximately 50 volunteers.

Conditions

Cataracts

Keywords

vision; Intraocular lenses

Outcome Measures

Primary Outcomes (1)

• To evaluate visual outcomes at distance, intermediate and near as well as range of vision and patient satisfaction after bilateral implantation of multifocal or accommodating IOLs post routine cataract extraction at least 3 months after surgery.

  six months

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 50 patients of both sexes and any race or ethnic background who underwent uneventful routine bilateral cataract extraction and multifocal or accomodating intraocular lens implantation will be included. Subjects will be divided in 5 groups of 10 subjects each based on the IOL implanted as follows: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, ReZoom, and Mix-and-match (patients implanted with ReSTOR in one eye and ReZoom in the fellow eye).

You may qualify if:

• Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
• Subject must have a multifocal or an accommodating IOL implanted bilaterally.
• Age: 40 to 90 years old.
• At least 3 months after cataract extraction and intraocular lens implantation in the second eye.
• Willing and able to comply with scheduled visit and other study procedures.

You may not qualify if:

• Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
• Ocular pathology affecting visual acuity: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy, macular degeneration (with best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
• Keratometric astigmatism exceeding 2.00 diopters.
• Planned postoperative refraction for mono-vision.
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
• Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in either eye.
• Other ocular surgery at the time of the cataract extraction.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Helga Sandoval, MD

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Helga P Sandoval, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 18, 2009

Record last verified: 2009-11

Locations

US (1)