NCT01507025

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

January 5, 2012

Last Update Submit

February 12, 2014

Conditions

Dry Eye

Keywords

hinge positiondry eye

Outcome Measures

Primary Outcomes (3)

  • 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

  • Tear break-up time

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

    6 months

  • Schirmer's I test

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

    6 months

Secondary Outcomes (1)

  • Corneal fluorescein staining

    6 months

Study Arms (2)

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)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

  • Feng YF, Yu JG, Wang DD, Li JH, Huang JH, Shi JL, Ye T, Wang QM, Zhao YE. The effect of hinge location on corneal sensation and dry eye after LASIK: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):357-66. doi: 10.1007/s00417-012-2078-5. Epub 2012 Jun 15.

    PMID: 22752222DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Yifan Feng, MD

    Eye Hospital, Wenzhou Medical College, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 10, 2012

Study Start

October 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

CN(1)