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Completed

NCT Number: NCT01507025

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

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).

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • each trial should be a prospective randomized controlled clinical trial (RCT),
  • the age of patient population should be over 18 years

Exclusion criteria

  • non-randomized controlled trials
  • patients who had had a previous ophthalmic surgery or ocular surface disorders
  • the raw data was not completed

Treatment and study plan

Primary outcomes

  1. 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.

  2. Tear break-up time

    Time frame: 6 months

    Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively

  3. Schirmer's I test

    Time frame: 6 months

    Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively

Secondary outcomes

  1. Corneal fluorescein staining

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Yifan Feng

Other

Collaborators

  • Wenzhou Medical University

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2012
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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