Skip to main content
OpenTrials
Completed

NCT Number: NCT01183702

Corneal Biomechanics With Hydration in Normal and LASIK Eyes

The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laser Corneal Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology Department (Gowdy Field Building, 5th Floor)

Columbus, Ohio, 43212, United States

About this study

The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas. Subjects' corneas will be swelled with warmed, humidified nitrogen using modified diving goggles to assess structural changes due to a two hour swelling period. Subjects will be examined prior to swelling by a registered ophthalmologist to ensure that the cornea is healthy enough to undergo the swelling procedure. Pre-swelling and post-swelling data will be compared for parameters such as elasticity, density, thickness, axial and tangential curvature, hydration, and intraocular pressure in the central, paracentral, and peripheral regions. Analysis of pre-swelling and post-swelling data will allow for a better understanding of the structural changes created by LASIK. In addition, this project will allow for a better understanding of how common fluctuations in hydration levels affect normal corneal parameters as given by common devices in both populations to allow for corrections for more accurate measurements.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.
  • Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.

Exclusion criteria

  • Children under 18.
  • Unhealthy cornea as determined by a registered ophthalmologist.

Treatment and study plan

LASIK surgery

Procedure

Participants have received LASIK surgery and their eyes are healthy.

Other names: Refractive Surgery

No intervention

Other

Participant has healthy eyes not altered by LASIK surgery.

Other names: Normal cornea, no refractive surgery

Primary outcomes

  1. Corneal hydration (swelling)

    Time frame: Two hours

Sponsors and collaborators

Lead sponsor

Deb Grzybowski

Other

Registry information

Official study title

Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2010
Registry last updated
Jan 13, 2017

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.