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The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis

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ClinicalTrials.gov Identifier: NCT01507025
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Wenzhou Medical University
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical University

Brief 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).

Condition or disease
Dry Eye

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 Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis
Study Start Date : October 2011
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Group/Cohort
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)



Primary Outcome Measures :
  1. 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.

  2. Tear break-up time [ Time Frame: 6 months ]
    Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively

  3. Schirmer's I test [ Time Frame: 6 months ]
    Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively


Secondary Outcome Measures :
  1. Corneal fluorescein staining [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients were scheduled to undergo LASIK and randomized to different hinge locations
Criteria

Inclusion Criteria:

  1. each trial should be a prospective randomized controlled clinical trial (RCT),
  2. the age of patient population should be over 18 years

Exclusion Criteria:

  1. non-randomized controlled trials
  2. patients who had had a previous ophthalmic surgery or ocular surface disorders
  3. the raw data was not completed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507025


Locations
China, Zhejiang
Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Yifan Feng
Wenzhou Medical University
Investigators
Principal Investigator: Yifan Feng, MD Eye Hospital, Wenzhou Medical College, China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yifan Feng, Study Director, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01507025     History of Changes
Other Study ID Numbers: Y20110045
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Yifan Feng, Wenzhou Medical University:
hinge position
dry eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases