Laser Corneal SurgeryNCT01183702
Corneal Biomechanics With Hydration in Normal and LASIK Eyes
A study testing LASIK surgery in people with Laser Corneal Surgery, run by Deb Grzybowski at 1 site in United States.
Trial summary
The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser Corneal Surgery
- What is being tested?
- LASIK surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.
- Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.
Who cannot join
- Children under 18.
- Unhealthy cornea as determined by a registered ophthalmologist.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmology Department (Gowdy Field Building, 5th Floor)
Columbus, Ohio, 43212
About this study
Official title: Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes
The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas.
Read the 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.
- Conditions
- Laser Corneal Surgery
- Being tested
- LASIK surgery, No Intervention
- Keywords
- LASIK vs. non-LASIK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK surgeryProcedure or surgery
Also called Refractive Surgery
Participants have received LASIK surgery and their eyes are healthy.
No InterventionOther
Also called Normal cornea, no refractive surgery
Participant has healthy eyes not altered by LASIK surgery.
| Study group | Role | What they receive |
|---|---|---|
| non-LASIK | Active comparator | These participants have NOT had LASIK surgery. Receives: Other: No Intervention |
| LASIK | Active comparator | These participants have had LASIK surgery. Receives: Procedure: LASIK surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal hydration (swelling)
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startFeb 2004
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser Corneal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deb Grzybowski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deb Grzybowski, Ohio State University
- Investigators
- Deborah M Grzybowski, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183702
- Sponsor's protocol ID
- 2004H002
- Status last verified
- Jan 2017
- First submitted
- 13 Aug 2010
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes
- ClinicalTrials.gov ID
- NCT01183702
- Acronym / sponsor ID
- 2004H002
- Conditions
- Laser Corneal Surgery
- Keywords
- LASIK vs. non-LASIK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Deb GrzybowskiUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-LASIK | Active comparator | Other: No InterventionThese participants have NOT had LASIK surgery. |
| LASIK | Active comparator | Procedure: LASIK surgeryThese participants have had LASIK surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.
- Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.
Key exclusion criteria (2 listed)
- Children under 18.
- Unhealthy cornea as determined by a registered ophthalmologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASIK surgeryAlso: Refractive SurgeryParticipants have received LASIK surgery and their eyes are healthy. | Procedure or surgery | LASIK |
| No InterventionAlso: Normal cornea, no refractive surgeryParticipant has healthy eyes not altered by LASIK surgery. | Other | non-LASIK |
Primary outcome
Corneal hydration (swelling)
Time frame: Two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah M Grzybowski, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASIK surgery in people with Laser Corneal Surgery, run by Deb Grzybowski at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal hydration (swelling) (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.