Status:
COMPLETED
Mechanical vs. Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures
Lead Sponsor:
Medical University of South Carolina
Conditions:
Keratomileusis, Laser In Situ
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A recent survey of trends among the members of the American Society of Cataract and Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading surgical procedure for photor...
Eligibility Criteria
Inclusion
- Subject must be a candidate for surface ablation procedures in both eyes.
- ≥ 18 years of age or older.
- Myopia ≤ -6.00 D.
- Astigmatism ≤ - 3.00 D.
- Manifest refraction spherical equivalent (MRSE) of -6.00 D.
- Capable of wearing a bandage contact lens.
- Willing and able to comply with scheduled visits and other study procedures.
Exclusion
- History of ocular pathology.
- Very large pupils (greater than 8mm diameter, infrared measurement).
- Thin corneas (preoperatively calculated minimal residual bed \< 250 um).
- If patient fit into the group of the usual exclusionary criteria (e.g. irregular astigmatism, asymmetric astigmatism, unstable refraction - most of these patients would not typically be considered LASIK candidates under normal circumstances).
- History of previous refractive surgery.
- Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities.
- 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 the operated eye.
- Use of any systemic or topical drug known to interfere with visual performance.
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control
- Inability or unwillingness of subjects to give written informed consent.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00366808
Start Date
February 1 2006
End Date
August 1 2007
Last Update
June 14 2018
Active Locations (1)
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1
Magill Laser Center, Medical University of South Carolina
Charleston, South Carolina, United States, 29425