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OpenTrials
Completed

NCT Number: NCT04738903

Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK

Corneal asphericity is expressed numerically as the "Q-value". A minus value means that corneal curvature flattens towards the periphery and the cornea is prolate in shape, but when the curvature steepens towards the periphery, the cornea is oblate in shape and has a positive Q-value.

The current study evaluates the effect of LASIK eye surgery on corneal asphericity by comparing 2 software treatment platforms; the Q value customized ablation versus the conventional Wave-front optimized ablation in a fellow eye study pattern.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TIBA eye center

Asyut, 71516, Egypt

About this study

The standard excimer laser correction of myopia is associated with decreased visual quality in the form of a decrease in contrast sensitivity and night vision. This degradation of the visual quality is attributed to changes in the corneal asphericity that increase the high order aberrations (HOAs), such as spherical aberrations because it leads to shifting of the corneal asphericity towards the oblate shape.

The wavefront-optimized (WFO) profile avoids the creation of new HOAs, but it is not able to treat those which are already present pre-operatively.

The Q-adjusted treatments correct the sphero-cylindrical refractive errors and try to maintain the corneal asphericity at the same time, but like the WFO ablation profiles, it is limited to correcting the spherical aberrations and not the non-rotational symmetric HOAs.

Some studies compared Lasers of two different platforms on contralateral eyes of the same patient in order to minimize inter-patient differences such as corneal wound healing and corneal biomechanics. By exclusion of these inter-patient differences, a more accurate judgment on the outcomes can be achieved.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Candidates for Laser vision correction (LVC) with

  • Myopic Spherical Equivalent up to -12 diopters.
  • Myopic astigmatism up to -6 diopters.
  • Corneal thinnest location ≥ 500 um 4- Residual stromal bed ≥ 300 um.

Exclusion criteria

  • Patients not candidates for LVC.
  • Hyperopic patients or mixed astigmatism.
  • Systemic disease that contraindicates LVC.
  • Intra- or post-operative complications. 5- Previous corneal surgery

Treatment and study plan

Femtosecond laser assisted LASIK eye surgery

Procedure

FS-LASIK eye surgery includes corneal flap creation with femtosecond laser using the Femtosecond laser WaveLight FS200 followed by excimer laser vision correction of the patient's refractive error using excimer laser WaveLight EX500.

Primary outcomes

  1. Postoperative Q value

    Time frame: 6 months

    Pentacam evaluation of post-LASIK Q value

Secondary outcomes

  1. Postoperative corneal thickness at the pupillary center

    Time frame: 6 months

    Pentacam evaluation of post-LASIK pachymetry at the pupil center

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK for Myopia and Myopic Astigmatism. A Contralateral Comparative Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2021
Registry last updated
Jul 20, 2021

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.