Accuracy of the Galilei Analyzer to Calculate the Effective Corneal Power After Corneal Refractive Surgery

NCT00934804 | Terminated

• 1 other identifier: 19183
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the accuracy of the Galilei corneal analyzer 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

Cataracts

Keywords

refractive surgery

Outcome Measures

Primary Outcomes (1)

• Accuracy of the Galilei 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.

  Three Months

Study Arms (1)

Comparative Diagnostic system

EXPERIMENTAL

Galilei dual Scheimpflug analyzer

Device: Galilei dual Scheimpflug analyzer

Interventions

Galilei dual Scheimpflug analyzer DEVICE

The Galilei dual Scheimpflug analyzer is a non-invasive, diagnostic system that combines dual rotating Scheimpflug camera measurements and Placido optical system for corneal topography and 3D analysis of the anterior eye segment.

Also known as: Holladay I, HofferQ, SRKT

Comparative Diagnostic system

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects MUST fulfill the following conditions to qualify for enrollment into the trial:
• 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:

• Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
• 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)

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

  Medical University of South Carolina, Storm Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 23, 2018

Record last verified: 2009-10

Locations

US (1)