NCT06739018

Brief Summary

The purpose of this study was to compare Scheimpflug corneal tomography findings in keratoconus and high myopic astigmatic eyes, as well as to establish the parameters distinguishing keratoconus from high myopic astigmatism.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 27, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

November 27, 2024

Last Update Submit

December 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • overall corneal mean difference thickness between keratoconus and mopc astigmatism

    Scheimpflug imaging uses a revolving Scheimpflug camera to determine the front and back surfaces of the cornea, hence measuring the overall corneal mean difference thickness between keratoconus and mopc astigmatism as regarding central anterior chamber depth

    baseline

Study Arms (2)

keratoconic group

patients with keratoconus

Other: pentacam scheimpflug tomography

high myopic astigmatim group

patients with high myopic astigmatism

Other: pentacam scheimpflug tomography

Interventions

Pentacam tomography is not radiation-based. It uses Scheimpflug imaging, which involves a rotating camera that captures multiple images of the anterior segment of the eye. The system employs light-based technology to measure the front and back surfaces of the cornea, along with the anterior chamber and lens, creating a 3D model of the anterior eye structures. it uses light instead of ionizing radiation (like X-rays), it is considered safe and non-invasive for routine use in ophthalmology. * It was used to assess 23 parameters from topographic maps and 15 parameters from Belin-Ambrosio enhanced ectasia (BAD) display maps. * Parameters included keratometry readings, anterior and posterior sagittal curvature, corneal thickness, anterior chamber volume, and several indices from the BAD display map. * These parameters were analyzed to discriminate between keratoconus and high myopic astigmatism using Receiver Operating Characteristic (ROC) curves for diagnostic accuracy.

high myopic astigmatim groupkeratoconic group

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The population represents individuals either have keratoconus or high mopic astigmatism and fit the inclusion and exclusion criteria to ensure proper comparison of corneal parameters .

You may qualify if:

  • keratoconus patient
  • virgin clear cornea with high myopic astigmatism
  • normal cornea with high myopic astigmatism

You may not qualify if:

  • patients had previous ocular surgery
  • ocular diseases rather than keratoconus
  • contact lens wearer
  • corneal opacity and corneal dystrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut university

Asyut, Asyut Governorate, 71526, Egypt

Location

Assiut university

Asyut, 71515, Egypt

Location

Related Publications (1)

  • Zaabaar E, Kyei S, Parkson Brew MAA, Boadi-Kusi SB, Assiamah F, Asiedu K. The utility of measures of anterior segment parameters of a Pentacam Scheimpflug tomographer in discriminating high myopic astigmatism from keratoconus. PLoS One. 2021 Dec 2;16(12):e0260648. doi: 10.1371/journal.pone.0260648. eCollection 2021.

    PMID: 34855828BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Momen Aly, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

youstena w saied, resident

CONTACT

Mohamed s abdalrahman, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 18, 2024

Study Start

December 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Locations