The Effect of Ablation Depth on Dry Eye After LASIK Treat... | NCT03228784

Studies
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia

NCT03228784

Sponsor

Minia University

Status

Completed

Last Update Posted

Jul 25, 2017Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Incidence and Severity of Dry Eye After Myopic LASIK

Interventions

LASIK

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2013Actual

Primary Completion Date

May 1, 2014Actual

Completion Date

May 1, 2014Actual

First Submitted Date

Jul 14, 2017

First Submission Date that Met QC Criteria

Jul 22, 2017

First Posted Date

Jul 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2017

Last Update Posted Date

Jul 25, 2017Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Name	Type	Description	Arm Group Labels	Other Names
LASIK	Procedure			Corneal Flap creation with mechanical microkeratome and stromal ablation with Excimerr laser.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of dry eye	Schirmer 1 test in millimeters	6 months
Degree of dryness	Tear break up time in seconds	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria :

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020731	Keratomileusis, Laser In Situ

Ancestor Terms

ID	Term
D048988	Corneal Surgery, Laser
D053685	Laser Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided