Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia

NCT00348049 | Completed

• 1 other identifier: R277/21/2002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 preferring LASIK to PRK because of better comfort and faster rehabilitation. However, in post-LASIK patients, there is a low risk of flap dislodgement. This risk increases with certain occupations which have a higher risk of trauma. Hence, there may be a role for PRK for people which such occupations, e.g. soldiers, parachutists, sportsman. There are several non-randomised studies which show that PRK is as efficacious, predictable and safe as LASIK for low to moderate myopes. But there have been only a few randomized controlled studies to compare the efficacy and safety of the 2 treatment modalities and all studies comparing LASIK and PRK suffer from a high dropout rate during the follow-up period. We compared the efficacy, predictability, stability and safety of LASIK versus PRK over a one year duration with almost 100% attendance during all follow-up visits.

Conditions

Myopia

Keywords

LASIK; PRK; Myopia

Outcome Measures

Primary Outcomes (1)

• Comparing the efficacy, predictability, stability and safety of LASIK versus PRK

Secondary Outcomes (3)

• Comparing wavefront aberrometry of LASIK vs PRK

• Comparing patient satisfaction of LASIK vs PRK

• Comparing effects of LASIK vs PRK in terms of post-surgery performance in the military setting

Interventions

Laser in Situ Keratomileusis (LASIK) PROCEDURE

Photorefractive Keratectomy (PRK) PROCEDURE

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Singapore Armed Forces: collaborator
• Defence Medical Environmental Research Institute: collaborator

Study Sites (1)

Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ; Photorefractive Keratectomy

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Donald Tan, FAMS

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

• Benjamin Seet

  Singapore Armed Forces

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: November 1, 2002
• Study Completion: August 1, 2005
• Last Updated: October 24, 2006

Record last verified: 2002-10

Locations

SG (1)