Status:
COMPLETED
Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia
Lead Sponsor:
Singapore National Eye Centre
Collaborating Sponsors:
Singapore Armed Forces
Defence Medical Environmental Research Institute
Conditions:
Myopia
Eligibility:
All Genders
21-40 years
Phase:
NA
Brief Summary
Laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) are currently the 2 main refractive surgeries to correct myopia which are being performed worldwide, with more patients prefe...
Detailed Description
This study is a prospective, randomized, clinical trial comparing the efficacy, predictability, stability and safety of LASIK versus PRK in a volunteer group of myopic military servicemen recruited fr...
Eligibility Criteria
Inclusion
- Male and female subjects were eligible for the study if they were 18 years old or older and had given informed consent; had stable myopia ranging from -2.00 to -5.00D of spherical equivalent myopia, but less than 2.00D of refractive astigmatism as determined by manifest refraction for at least 6 months; a best corrected visual acuity of at least 20/20 and a stable keratometry after not wearing soft contact lenses for at least 2 weeks and hard lenses for at least 3 weeks. Study subjects were required to have a minimum cornea thickness of at least 460um as measured by Orbscan pachymetry.
Exclusion
- Subjects were excluded if they had corneal or anterior segment pathology, or myopic peripheral retinal degeneration or myopic macular degeneration; clinical signs of progressive or unstable myopia or keratoconus or were keratoconus suspects; were one-eyed patients; had undergone previous ocular surgery; had a history of herpes zoster ophthalmicus or herpes simplex keratitis; had a history of steroid-responsive rise in intraocular pressure or had a preoperative intraocular pressure of more than 21 mmHg in either eye; had diabetes mellitus, auto-immune disease, severe dry eye, connective tissue disease or significant atopy; on chronic systemic corticosteroid or immunosuppressive therapy; had a cornea thickness which would have resulted in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively or had a central corneal endothelial cell count of less than 1500 cells/mm2 in either eye
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00348049
Start Date
November 1 2002
End Date
August 1 2005
Last Update
October 24 2006
Active Locations (1)
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1
Singapore Eye Research Institute
Singapore, Singapore, 168751