Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery

NCT00466908 | Withdrawn

• 1 other identifier: MRC-07-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.

Conditions

Cataract Extraction; Refractive Surgery

Interventions

Pentacam and IOL Master DEVICE

Pentacam and IOL Master

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subject must have undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction. Age: 40 to 80 years old.

You may qualify if:

• Subject must have undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction.
• Age: 40 to 80 years old.
• Subjects must have undergone cataract extraction at least 4 weeks prior to enrollment in this trial.
• Willing and able to comply with scheduled visits and other study procedures.

You may not qualify if:

• Preoperative ocular pathology: 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, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
• 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.
• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
• 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 (other than cataract extraction) within the past three months or intraocular laser surgery within one month in the operated eye.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Helga Sandoval, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: March 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 6, 2018

Record last verified: 2010-10

Locations

US (1)