Optical Coherence Pachymetry to Evaluate Central Corneal... | NCT02893644

Studies
Optical Coherence Pachymetry to Evaluate Central Corneal Ablation Depth in Myopic Femtosecond Laser in Situ Keratomileusis

NCT02893644

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Mar 20, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Myopia

Interventions

Not provided

Countries

France

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

Mar 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

May 26, 2014Actual

Primary Completion Date

Jul 26, 2016Actual

Completion Date

Mar 15, 2017Actual

First Submitted Date

Aug 30, 2016

First Submission Date that Met QC Criteria

Sep 2, 2016

First Posted Date

Sep 8, 2016Estimated

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

Mar 17, 2017

Last Update Posted Date

Mar 20, 2017Actual

Description Module

Brief Summary

Prospective study aiming to measure central ablation depth during excimer laser surgery in myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP, before and after laser ablation. This measurement will be compared with pre and 1 month postoperative topography differential pachymetric measurements.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
depth of central corneal ablation	measured in microns with OCP	1 month after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 18 years old
undergoing refractive surgery with LASIK
with myopic or compound myopic astigmatism ametropia
without irregular cornea and topographical sign of keratoconus
preoperative corneal thickness compatible with LASIK

Exclusion Criteria:

hyperopia
opposition to participate in the study
no health insurance coverage
patient under legal protection
pregnant or breastfeeding patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing refractive surgery with LASIK

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Luc FEBBRARO, MD	Fondation OPH A de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SALOMON		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided