IOP Measurements Using ORA After ACXL in Keratoconus | NCT04464083

Studies
IOP Measurements Using ORA After ACXL in Keratoconus

NCT04464083

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Feb 3, 2021Actual

Enrollment

20Actual

Phase

Not provided

Conditions

IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL)

Interventions

IOP Measurment

Countries

Egypt

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

Feb 2021

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

Apr 12, 2020Actual

Primary Completion Date

Oct 15, 2020Actual

Completion Date

Oct 15, 2020Actual

First Submitted Date

Jul 5, 2020

First Submission Date that Met QC Criteria

Jul 8, 2020

First Posted Date

Jul 9, 2020Actual

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

Feb 1, 2021

Last Update Posted Date

Feb 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators measured IOP by Goldmann applanation tonometry(GAT) before and 6 months after accelerated 8 minutes CXL in using Avedro Kxl ,and correlated with corneal resistance factor(CRF)using ORA, AC angle and CCT using Scheimpflug imaging.

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

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IOP Measurment	Diagnostic Test	To determine IOP readings before and after accelerated corneal collagen crosslinking (CXL)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine IOP readings before and after accelerated corneal collagen crosslinking		April-October 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

KC patient indicated for CXL

Exclusion Criteria:

Advanced KC Glaucoma patients

Accepts Healthy Volunteers

Not provided

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

all patients with KC and indicated for CXL

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

approval from the principal investigator

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided