Dry EyeNCT01507025
The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis
An observational study of Dry Eye, run by Yifan Feng at 1 site in China.
Trial summary
The purpose of this study is to investigate the possible effect of hinge location on corneal sensation and dry eye syndrome after laser in situ keratomileusis (LASIK). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dry Eye
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Feb 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients were scheduled to undergo LASIK and randomized to different hinge locations
Who may be able to join
- each trial should be a prospective randomized controlled clinical trial (RCT),
- the age of patient population should be over 18 years
Who cannot join
- non-randomized controlled trials
- patients who had had a previous ophthalmic surgery or ocular surface disorders
- the raw data was not completed
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the possible effect of hinge location on corneal sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).
Read the detailed description
Dry eye symptoms are a frequent postoperative complication of laser in situ keratomileusis (LASIK). Although estimates of the incidence of dry eye syndrome vary widely, from 3% to 59%, almost all patients will have transient dry eye during the immediate postoperative period.Because of the variability in corneal innervation patterns, altering flap characteristics in LASIK may affect postoperative corneal sensation and dry-eye disease. Some studies have reported that postoperative corneal sensation may be higher and recovery faster in eyes with horizontal flaps (nasal- or temporal-hinge) than in eyes with vertical flaps (superior- hinge). However, some other studies have not established an association between corneal sensation and hinge position. This study reviewed the published literature and performed a meta-analysis aimed to investigate the effects of hinge location on corneal sensation and dry-eye symptoms after LASIK.
- Conditions
- Dry Eye
- Keywords
- hinge position, dry eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| horizontal flap | patients were scheduled to undergo LASIK and with horizontal flaps(nasal- or temporal-hinge) | |
| vertical flap | patients were scheduled to undergo LASIK and with vertical flaps(superior- hinge) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal sensitivity
Change of corneal sensitivity by using the Cochet-Bonnet esthesiometer,we chose to analyze results at 1 week and 1-, 3-, 6-month postoperatively.
Measured: 6 months
Tear break-up time
Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively
Measured: 6 months
Schirmer's I test
Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively
Measured: 6 months
Secondary outcomes (1)
Corneal fluorescein staining
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yifan Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Medical University
- Responsible party
- Sponsor-investigator, Yifan Feng, Wenzhou Medical University
- Investigators
- Yifan Feng, MD, Principal investigator, Eye Hospital, Wenzhou Medical College, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507025
- Sponsor's protocol ID
- Y20110045
- Status last verified
- Feb 2014
- First submitted
- 5 Jan 2012
- Last updated
- 13 Feb 2014
- Results posted
- No
Publications
Feng YF, Yu JG, Wang DD, Li JH, Huang JH, Shi JL, Ye T, Wang QM, Zhao YE. The effect of hinge location on corneal sensation and dry eye after LASIK: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):357-66. doi: 10.1007/s00417-012-2078-5. Epub 2012 Jun 15.
PubMed 22752222
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT01507025
- Acronym / sponsor ID
- Y20110045
- Conditions
- Dry Eye
- Keywords
- hinge position, dry eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yifan FengUniversity, hospital or other
- Collaborators
- Wenzhou Medical University
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jan 2012 (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 purpose of this study is to investigate the possible effect of hinge location on corneal sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).
Detailed description
Dry eye symptoms are a frequent postoperative complication of laser in situ keratomileusis (LASIK). Although estimates of the incidence of dry eye syndrome vary widely, from 3% to 59%, almost all patients will have transient dry eye during the immediate postoperative period.Because of the variability in corneal innervation patterns, altering flap characteristics in LASIK may affect postoperative corneal sensation and dry-eye disease. Some studies have reported that postoperative corneal sensation may be higher and recovery faster in eyes with horizontal flaps (nasal- or temporal-hinge) than in eyes with vertical flaps (superior- hinge). However, some other studies have not established an association between corneal sensation and hinge position. This study reviewed the published literature and performed a meta-analysis aimed to investigate the effects of hinge location on corneal sensation and dry-eye symptoms after LASIK.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| horizontal flap | – | –patients were scheduled to undergo LASIK and with horizontal flaps(nasal- or temporal-hinge) |
| vertical flap | – | –patients were scheduled to undergo LASIK and with vertical flaps(superior- hinge) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients were scheduled to undergo LASIK and randomized to different hinge locations
Key inclusion criteria (2 listed)
- each trial should be a prospective randomized controlled clinical trial (RCT),
- the age of patient population should be over 18 years
Key exclusion criteria (3 listed)
- non-randomized controlled trials
- patients who had had a previous ophthalmic surgery or ocular surface disorders
- the raw data was not completed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corneal sensitivity
Time frame: 6 months
Change of corneal sensitivity by using the Cochet-Bonnet esthesiometer,we chose to analyze results at 1 week and 1-, 3-, 6-month postoperatively.
Tear break-up time
Time frame: 6 months
Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively
Schirmer's I test
Time frame: 6 months
Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively
1 secondary outcome
Corneal fluorescein staining
Time frame: 6 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 13 Feb 2014.
- Derived from this study: PubMed 22752222Feng YF, Yu JG, Wang DD, Li JH, Huang JH, Shi JL, Ye T, Wang QM, Zhao YE. The effect of hinge location on corneal sensation and dry eye after LASIK: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):357-66. doi: 10.1007/s00417-012-2078-5. Epub 2012 Jun 15.
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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.
Yifan Feng, MD principal investigator
Eye Hospital, Wenzhou Medical College, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Yifan Feng at 1 site in China.
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 3 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 Feb 2014. 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 China. 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 sensitivity (time frame: 6 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?
On the ClinicalTrials.gov record for NCT01507025, which also lists 1 linked publication.
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 Feb 2014.