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Completed

NCT Number: NCT02210793

Dry Eye Evaluation After Transepithelial PRK

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Nour Eye Hospital

Giza, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transepithelial PRK

Procedure

LASIK

Procedure

Primary outcomes

  1. qualitative assessment of dry eye syndrome

    Time frame: 6 months

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

  2. quantitative of dry eye after surgery

    Time frame: 6 months

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

Secondary outcomes

  1. haze

    Time frame: 6 months

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

Other outcomes

  1. healing time of epithelial defect epithelial defect

    Time frame: 2-5 days

    the period of time in days needed for complete healing of the epithelial defect created during transepithelial PRK

Sponsors and collaborators

Lead sponsor

AL-Nour Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 7, 2014
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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