Dry Eye Evaluation After Transepithelial PRK

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Procedure: LASIK; Procedure: transepithelial PRK

• Registration Number: NCT02210793
• Lead Sponsor: AL-Nour Eye Hospital

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

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-08
• Study First Submitted: 2014-08-02
• Study First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Study First Posted: 2014-08-07
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• Pregnancy and lactation
• Keratoconus
• Previous refractive surgery
• Previous herpetic keratitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional LASIK	LASIK	20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)
Transepithelial PRK	transepithelial PRK	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)

Primary Outcome Measures

Name	Time	Method
qualitative assessment of dry eye syndrome	6 months	Tear Break Up time is used as a qualitative measure of dry eye after surgery
quantitative of dry eye after surgery	6 months	Schirmer test is used as a quantitative measure of dry eye after surgery

Secondary Outcome Measures

Name	Time	Method
haze	6 months	haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system

Trial Locations

Locations (1)

Al Nour Eye Hospital; 🇪🇬 Giza, Egypt