Text Size

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

This study is currently recruiting participants.
Verified January 2013 by Wenzhou Medical University
Sponsor:
Collaborator:
Wenzhou Medical University
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01507025
First received: January 5, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • Corneal sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively

  • Schirmer's I test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507025

Contacts
Contact: Yifan Feng, MD 86-577-88068880 wzafengyifan@163.com
Contact: Yune Zhao, MD 86-577-88068880 zye@mail.eye.ac.cn

Locations
China, Zhejiang
Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Yifan Feng, MD     +86-577-88068880     wzafengyifan@163.com    
Sponsors and Collaborators
Yifan Feng
Wenzhou Medical University
Investigators
Principal Investigator: Yifan Feng, MD Eye Hospital, Wenzhou Medical College, China
  More Information

No publications provided by Wenzhou Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yifan Feng, Study Director, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01507025     History of Changes
Other Study ID Numbers: Y20110045
Study First Received: January 5, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013