Analysis of Topographic Corneal Parameters | NCT06220578

Studies
Analysis of Topographic Corneal Parameters

NCT06220578

Sponsor

Minia University

Status

Completed

Last Update Posted

Jan 24, 2024Actual

Enrollment

2,694Actual

Phase

Not provided

Conditions

Cornea

Interventions

Oculus pentacam HR

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

Jan 2024

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

Jan 1, 2023Actual

Primary Completion Date

Aug 30, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jan 12, 2024

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Jan 24, 2024Actual

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

Jan 23, 2024

Last Update Posted Date

Jan 24, 2024Actual

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 Pentacam HR system (OCULUS) has been suggested to be one of the most sensitive instruments for corneal examination before corneal refractive surgery

Detailed Description

Retrospective non randomized study Analysis of different corneal paremeters obtained by Pentacam for corneal refractive surgery candidates during last 3 years from both sexes between 18 and 45 years K1 - K2 - K max - Pachymetry apex - Pachymetry thinnest - Distance between apex and thinnest - Back elevation - Topography shape - Keratoconus (If present)

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

2,694Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
candidates seeking corneal refractive surgery		Persons from both sexes between 18 and 45 years seeking corneal refractive surgery	Device: Oculus pentacam HR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oculus pentacam HR	Device	Examination of corneal parameters by pentacam	candidates seeking corneal refractive surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
corneal curvature	radii of curvature in diopters	7 months
corneal pachymetry	measured in microns	7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons from both sexes between 18 and 45 years seeking corneal refractive surgery

Exclusion Criteria:

Previous intraocular surgery
Previous corneal surgery
Corneal opacity

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

patients examined in Roaa LASIK center from both sexes between 18-45 years seeking corneal refractive surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Abdelghany, professor	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Minya			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

not plan to share

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided