Comparison Between Handheld Rebound Tonometer and Applana... | NCT06766799

Studies
Comparison Between Handheld Rebound Tonometer and Applanation Tonometer in IOP Measurement in Paediatric Glaucomas

NCT06766799

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Jan 9, 2025Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Glaucoma

Interventions

Rebound and Applanation Tonometer

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

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Estimated

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jan 5, 2025

First Submission Date that Met QC Criteria

Jan 5, 2025

First Posted Date

Jan 9, 2025Actual

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 5, 2025

Last Update Posted Date

Jan 9, 2025Actual

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

To compare the accuracy between handheld rebound tonometer & applanation tonometer in IOP measurement in pediatric glaucoma cases

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

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A ( Glaucomatous Patients)			Device: Rebound and Applanation Tonometer
Group B ( Control Group)			Device: Rebound and Applanation Tonometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rebound and Applanation Tonometer	Device	Measurement of Intraocular Pressure	Group A ( Glaucomatous Patients) Group B ( Control Group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between the IOP Measurments by Rebound Tonometer & Applanation tonometer	To compare the accuracy between handheld rebound tonometer & applanation tonometer in IOP measurement in pediatric glaucoma cases	over nine months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients attending to our pediatric glaucoma clinic diagnosed with glaucoma aged >18 years old are subjected to IOP Measurements.

Exclusion Criteria:

**Patients aged more than 18 years old
- patients with scarred cornea

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

100 Cases of Glaucomatous Patients and 60 Cases of Healthy Individuals

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided