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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507025
First Posted: January 10, 2012
Last Update Posted: February 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wenzhou Medical University
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical University
  Purpose
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
Dry Eye

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yifan Feng, Wenzhou Medical University:

Primary Outcome Measures:
  • 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


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

Estimated Enrollment: 400
Study Start Date: October 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.
  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: January 5, 2012
First Posted: January 10, 2012
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