Dry Eye Evaluation After Transepithelial PRK

NCT ID: NCT02210793

Last Updated: 2014-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

transepithelial PRK

Intervention Type PROCEDURE

Conventional 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)

Group Type ACTIVE_COMPARATOR

LASIK

Intervention Type PROCEDURE

Interventions

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transepithelial PRK

Intervention Type PROCEDURE

LASIK

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AL-Nour Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Sherif

Dr Ahmed Sherif

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M Shalaby, MD

Role: STUDY_DIRECTOR

Cairo University

Mahmoud H Abu Steit, MD

Role: STUDY_DIRECTOR

Cairo University

Mohamed Salah, MBBCH

Role: STUDY_DIRECTOR

Cairo University

Locations

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Al Nour Eye Hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ANH-TPRK1

Identifier Type: OTHER

Identifier Source: secondary_id

ANH-1

Identifier Type: -

Identifier Source: org_study_id

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