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Corneal Biomechanics With Hydration in Normal and LASIK Eyes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01183702
Enrollment
44
Registered
2010-08-18
Start date
2004-02-29
Completion date
2012-12-31
Last updated
2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laser Corneal Surgery

Keywords

LASIK vs. non-LASIK

Brief summary

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

Detailed description

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.

Interventions

PROCEDURELASIK surgery

Participants have received LASIK surgery and their eyes are healthy.

OTHERNo Intervention

Participant has healthy eyes not altered by LASIK surgery.

Sponsors

Deb Grzybowski
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Corneal hydration (swelling)Two hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026