NCT02210793

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

August 2, 2014

Last Update Submit

August 5, 2014

Conditions

Dry Eye

Keywords

Transepithelial PRKDry eyeSchirmer testTear break up timeDry eye after advanced surface ablation technique

Outcome Measures

Primary Outcomes (2)

  • qualitative assessment of dry eye syndrome

    Tear Break Up time is used as a qualitative measure of dry eye after surgery

    6 months

  • quantitative of dry eye after surgery

    Schirmer test is used as a quantitative measure of dry eye after surgery

    6 months

Secondary Outcomes (1)

  • haze

    6 months

Other Outcomes (1)

  • healing time of epithelial defect epithelial defect

    2-5 days

Study Arms (2)

Transepithelial PRK

ACTIVE COMPARATOR

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)

Procedure: transepithelial PRK

Conventional LASIK

ACTIVE COMPARATOR

20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)

Procedure: LASIK

Interventions

transepithelial PRKPROCEDURE
Transepithelial PRK
LASIKPROCEDURE
Conventional LASIK

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Myopia -1 to -6 diopters
  • Astigmatism -0.5 to - 4 diopters

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Nour Eye Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Officials

  • Ahmed M Shalaby, MD

    Cairo University

    STUDY DIRECTOR

  • Mahmoud H Abu Steit, MD

    Cairo University

    STUDY DIRECTOR

  • Mohamed Salah, MBBCH

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Ahmed Sherif

Study Record Dates

First Submitted

August 2, 2014

First Posted

August 7, 2014

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

EG(1)