The Lamina Cribrosa and Optic Nerve Head ChangesNCT02676557
The Lamina Cribrosa (LC) Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)
An observational study of The Lamina Cribrosa and Optic Nerve Head Changes, run by Samsung Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Lamina Cribrosa and Optic Nerve Head Changes
- What is being tested?
- Exposed to the high pressure during the surgery
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Mar 2015
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The myopic patients who were supposed to undergo LASIK surgery
Who may be able to join
- the myopic patients who were supposed to undergo LASIK surgery in the Samsung Medical Center
Who cannot join
- Optic nerve head abnormalities at preoperative examination
- Previous ocular surgical history
About this study
Official title: The Lamina Cribrosa (LC) Morphologic 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.
- Being tested
- Exposed to the high pressure during the surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed to the high pressure during the surgeryDevice
| Study group | Role | What they receive |
|---|---|---|
| LASIK | Not described Receives: Device: Exposed to the high pressure during the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of lamina cribrosa (LC) depth
micro millimeter
Measured: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Change of lamina cribrosa (LC) thickness
micro millimeter
Measured: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Change of optic nerve head (ONH) width
micro millimeter
Measured: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Secondary outcomes (1)
Change of optic nerve head minimum rim width
micro millimeter
Measured: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Lamina Cribrosa and Optic Nerve Head ChangesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changwon Kee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676557
- Sponsor's protocol ID
- LASIK-LC study
- Status last verified
- Feb 2016
- First submitted
- 19 Oct 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lamina Cribrosa (LC) Morphologic Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)
- ClinicalTrials.gov ID
- NCT02676557
- Acronym / sponsor ID
- LASIK-LC study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Feb 2016 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LASIK | – | Device: Exposed to the high pressure during the surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The myopic patients who were supposed to undergo LASIK surgery
Key inclusion criteria (1 listed)
- the myopic patients who were supposed to undergo LASIK surgery in the Samsung Medical Center
Key exclusion criteria (2 listed)
- Optic nerve head abnormalities at preoperative examination
- Previous ocular surgical history
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 |
|---|---|---|
| Exposed to the high pressure during the surgery | Device | LASIK |
Primary outcome
Change of lamina cribrosa (LC) depth
Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
micro millimeter
Change of lamina cribrosa (LC) thickness
Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
micro millimeter
Change of optic nerve head (ONH) width
Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
micro millimeter
1 secondary outcome
Change of optic nerve head minimum rim width
Time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
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 8 Feb 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of The Lamina Cribrosa and Optic Nerve Head Changes, run by Samsung Medical Center.
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 1 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of lamina cribrosa (LC) depth (time frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months). The study lists 3 primary outcomes in all. 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 8 Feb 2016.