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OpenTrials
Completed

NCT Number: NCT02676557

The Lamina Cribrosa (LC) Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)

The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study. In the present study, the investigators intended to investigate whether the changes of the deep and superficial structures around ONH exist or not using EDI OCT.

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Key information

Conditions

The Lamina Cribrosa and Optic Nerve Head Changes

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the myopic patients who were supposed to undergo LASIK surgery in the Samsung Medical Center

Exclusion criteria

  • Optic nerve head abnormalities at preoperative examination
  • Previous ocular surgical history

Treatment and study plan

Exposed to the high pressure during the surgery

Device

Primary outcomes

  1. Change of lamina cribrosa (LC) depth

    Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months

    micro millimeter

  2. Change of lamina cribrosa (LC) thickness

    Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months

    micro millimeter

  3. Change of optic nerve head (ONH) width

    Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months

    micro millimeter

Secondary outcomes

  1. Change of optic nerve head minimum rim width

    Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months

    micro millimeter

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Lamina Cribrosa (LC) Morphologic Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 8, 2016
Registry last updated
Feb 8, 2016

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.