NCT03228784

Brief Summary

The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

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

June 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

July 14, 2017

Last Update Submit

July 22, 2017

Conditions

Incidence and Severity of Dry Eye After Myopic LASIK

Outcome Measures

Primary Outcomes (2)

  • Incidence of dry eye

    Schirmer 1 test in millimeters

    6 months

  • Degree of dryness

    Tear break up time in seconds

    6 months

Interventions

LASIKPROCEDURE
Also known as: Corneal Flap creation with mechanical microkeratome and stromal ablation with Excimerr laser.

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with age ≥ 21 years
  • Normal Pentacam maps
  • Myopia with spherical equation less than 12 D
  • Corneal thickness ≥ 500 Microns
  • Calculated residual stromal bed ≥ 280 microns
  • No signs or symptoms of dry eye.

You may not qualify if:

  • Keratoconus and forme fruste keratoconus
  • Auto-immune diseases
  • History of dry eye or previous use of tear substitutes
  • Previous ocular surgery
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Keratomileusis, Laser In Situ

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 25, 2017

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 25, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share