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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01507025
Other study ID # Y20110045
Secondary ID
Status Completed
Phase N/A
First received January 5, 2012
Last updated February 12, 2014
Start date October 2011
Est. completion date February 2014

Study information

Verified date February 2014
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Wenzhou Medical College Wenzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Yifan Feng Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months No
Primary Tear break-up time Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively 6 months No
Primary Schirmer's I test Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively 6 months No
Secondary Corneal fluorescein staining 6 months No
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