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NCT02210793 Clinical Trial

Dry Eye Evaluation After Transepithelial PRK

Dry Eye Clinical Trial

Official title:
Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02210793
Other study ID # ANH-1
Secondary ID ANH-TPRK1
Status Completed
Phase N/A
First received August 2, 2014
Last updated August 5, 2014
Start date April 2012
Est. completion date March 2013

Study information
Verified date August 2014
Source AL-Nour Eye Hospital
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Procedure:
• transepithelial PRK

• LASIK

Locations
Country Name City State
Egypt Al Nour Eye Hospital Giza

Sponsors (1)
Lead Sponsor Collaborator
AL-Nour Eye Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other healing time of epithelial defect epithelial defect the period of time in days needed for complete healing of the epithelial defect created during transepithelial PRK 2-5 days Yes
Primary qualitative assessment of dry eye syndrome Tear Break Up time is used as a qualitative measure of dry eye after surgery 6 months Yes
Primary quantitative of dry eye after surgery Schirmer test is used as a quantitative measure of dry eye after surgery 6 months Yes
Secondary haze haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system 6 months Yes
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