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Completed

NCT Number: NCT04452448

Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Alexandria Faculty of Medicine

Alexandria, Egypt

About this study

The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Myopia up to -8.0 D and astigmatism up to -2.0D.
  • Cases above 18 years of age with a stable refraction for at least one year.

Exclusion criteria

  • Keratoconus.
  • Patients with collagen diseases.
  • Previous LASIK or any other refractive surgery.
  • Severe dry eye syndrome.

Treatment and study plan

LASIK

Device

All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.

Primary outcomes

  1. Evaluation of ocular aberrations

    Time frame: 3 months

    • Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery

  2. Visual acuity

    Time frame: 3 months

    Unaided as well as best corrected visual acuity

  3. Manifest refraction

    Time frame: 3 months

    Manifest refraction

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Jun 30, 2020

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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