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

February 12, 2014 updated by: Yifan Feng
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).

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients were scheduled to undergo LASIK and randomized to different hinge locations

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Tear break-up time
Time Frame: 6 months
Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively
6 months
Schirmer's I test
Time Frame: 6 months
Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal fluorescein staining
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yifan Feng

Collaborators

Wenzhou Medical University

Investigators

  • Principal Investigator: Yifan Feng, MD, Eye Hospital, Wenzhou Medical College, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y20110045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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