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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Laser in Situ Keratomileusis (LASIK)
Photorefractive Keratectomy (PRK)
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring LASIK, PRK, Myopia

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Singapore Eye Research Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2006
Last Updated
October 23, 2006
Sponsor
Singapore National Eye Centre
Collaborators
Singapore Armed Forces, Defence Medical Environmental Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00348049
Brief Title
Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia
Official Title
A Prospective, Randomized Trial Evaluating the Operational Efficacy of LASIK vs. PRK for the Correction of Low and Moderate Myopia in the Singapore Armed Forces
Study Type
Interventional

2. Study Status

Record Verification Date
October 2002
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Singapore National Eye Centre
Collaborators
Singapore Armed Forces, Defence Medical Environmental Research Institute

4. Oversight

5. Study Description

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.
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 from the Singapore Armed Forces. 132 subjects who were eligible for the study were randomized to undergo either LASIK or PRK in both eyes in a 2:1 ratio. 45 subjects (90 eyes) underwent PRK and 87 subjects (174 eyes) underwent LASIK. An additional 59 subject underwent a non-randomised arm of the study and underwent PRK.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
LASIK, PRK, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laser in Situ Keratomileusis (LASIK)
Intervention Type
Procedure
Intervention Name(s)
Photorefractive Keratectomy (PRK)
Primary Outcome Measure Information:
Title
Comparing the efficacy, predictability, stability and safety of LASIK versus PRK
Secondary Outcome Measure Information:
Title
Comparing wavefront aberrometry of LASIK vs PRK
Title
Comparing patient satisfaction of LASIK vs PRK
Title
Comparing effects of LASIK vs PRK in terms of post-surgery performance in the military setting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Tan, FAMS
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Seet
Organizational Affiliation
Singapore Armed Forces
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

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

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