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

Completed

• Conditions: Dry Eye

• Registration Number: NCT01507025
• Lead Sponsor: Yifan Feng

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).

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal sensitivity	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	6 months	Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively
Schirmer's I test	6 months	Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively

Secondary Outcome Measures

Name	Time	Method
Corneal fluorescein staining	6 months

Trial Locations

Locations (1)

Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China