NCT06348368

Brief Summary

Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

March 27, 2024

Last Update Submit

April 6, 2024

Conditions

Corneal Ectasia

Outcome Measures

Primary Outcomes (1)

  • Values anterior and posterior corneal elevation values by pentacam.

    Corneal topgraphic changes in children with high cylinder in upper Egypt

    one year

Study Arms (3)

Group 1 (control group)

Children with normal Pentacam and with no refractive errors

Other: Pentacam and autorefractometry

Group 2 (children with high cylinder and no corneal topographic abnormalities)

Children with high cylinder without corneal topographic ectasia.

Other: Pentacam and autorefractometry

Group 3 (Children with high cylinder and corneal ectatic changes).

Children with high cylinder and corneal ectatic changes

Other: Pentacam and autorefractometry

Interventions

Pentacam and autorefractometryOTHER

Pentacam to detect corneal topographic changes. Auto-refractometry to assess refraction condition of the children

Group 1 (control group)Group 2 (children with high cylinder and no corneal topographic abnormalities)Group 3 (Children with high cylinder and corneal ectatic changes).

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children live in upper Egypt with high cylinder and no corneal scar.

You may qualify if:

  • \- Upper Egypt children with high cylinder(refractive errorr).

You may not qualify if:

  • Children below age of 7 years old (uncooperative), patients above age of 18 years old.Patients with corneal scars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elshimaa A.Mateen

Sohag, Egypt

Location

Study Officials

  • Elshimaa A.Mateen

    Assistant professor of ophthalmology, Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 4, 2024

Study Start

January 1, 2023

Primary Completion

January 30, 2024

Study Completion

February 1, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

EG(1)