Back to resultsDry Eye Evaluation After Transepithelial PRK
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transepithelial PRK
LASIK
Sponsored by
About this trial
This is an interventional screening trial for Dry Eye focused on measuring Transepithelial PRK, Dry eye, Schirmer test, Tear break up time, Dry eye after advanced surface ablation technique
Eligibility Criteria
Inclusion Criteria
- Myopia -1 to -6 diopters
- Astigmatism -0.5 to - 4 diopters
Exclusion Criteria:
- Pregnancy and lactation
- Keratoconus
- Previous refractive surgery
- Previous herpetic keratitis
Sites / Locations
- Al Nour Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transepithelial PRK
Conventional LASIK
Arm Description
20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany)
20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)
Outcomes
Primary Outcome Measures
qualitative assessment of dry eye syndrome
Tear Break Up time is used as a qualitative measure of dry eye after surgery
quantitative of dry eye after surgery
Schirmer test is used as a quantitative measure of dry eye after surgery
Secondary Outcome Measures
haze
haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02210793
Brief Title
Dry Eye Evaluation After Transepithelial PRK
Official Title
Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AL-Nour Eye Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik
Detailed Description
Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Transepithelial PRK, Dry eye, Schirmer test, Tear break up time, Dry eye after advanced surface ablation technique
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transepithelial PRK
Arm Type
Active Comparator
Arm Description
20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany)
Arm Title
Conventional LASIK
Arm Type
Active Comparator
Arm Description
20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)
Intervention Type
Procedure
Intervention Name(s)
transepithelial PRK
Intervention Type
Procedure
Intervention Name(s)
LASIK
Primary Outcome Measure Information:
Title
qualitative assessment of dry eye syndrome
Description
Tear Break Up time is used as a qualitative measure of dry eye after surgery
Time Frame
6 months
Title
quantitative of dry eye after surgery
Description
Schirmer test is used as a quantitative measure of dry eye after surgery
Time Frame
6 months
Secondary Outcome Measure Information:
Title
haze
Description
haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
healing time of epithelial defect epithelial defect
Description
the period of time in days needed for complete healing of the epithelial defect created during transepithelial PRK
Time Frame
2-5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Myopia -1 to -6 diopters
Astigmatism -0.5 to - 4 diopters
Exclusion Criteria:
Pregnancy and lactation
Keratoconus
Previous refractive surgery
Previous herpetic keratitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shalaby, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoud H Abu Steit, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Salah, MBBCH
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Al Nour Eye Hospital
City
Giza
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Dry Eye Evaluation After Transepithelial PRK
We'll reach out to this number within 24 hrs