Anterior Segment and Corneal Parameters in Keratoconus and High Myopic Astigmatism Using Schiempflug Imaging

December 16, 2024 updated by: Youstena Saied Waheb, Assiut University

Comparison of Anterior Segment and Corneal Parameters in Keratoconus and High Myopic Astigmatism Using Schiempflug Imaging

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.

Study Overview

Status

Not yet recruiting

Detailed Description

Keratoconus is a progressive, non-inflammatory corneal ecstatic disorder caused by alteration in the structure and organization of corneal collagen fibers. It results in uneven steepening of the cornea, resulting in irregular astigmatism that cannot be totally corrected with glasses, impairing the quality of life . However, in many cases, increased axial length adds to the myopic component of refractive error . Thereafter, keratoconus patients frequently have axial high myopia with irregular astigmatism . Furthermore, early diagnosis of keratoconus aids in the timely management of the condition, thus improving patients' quality of life. According to research, high myopia, in addition to the degree of astigmatism, is an alarming sign that requires further corneal assessment to rule out any corneal abnormalities such as keratoconus. Furthermore, keratoconus could be misdiagnosed as meridional amblyopia attributable to myopic astigmatism due to the lack of corneal tomography measurements . As a result, it is critical to evaluate all high myopia patients, particularly those considering refractive surgery, for high-risk corneas.

The criteria for diagnosing and classifying keratoconus are based on anterior corneal curvature data obtained using Placido-based corneal topography . Early alterations in eyes with keratoconus, however, have been found on the posterior corneal surface . Scheimpflug imaging uses a revolving Scheimpflug camera to determine the front and back surfaces of the cornea, hence measuring the overall thickness. Several studies have utilized Scheimpflug tomography to evaluate anterior segment parameters between normal eyes and eyes with keratoconus , but the utility of Scheimpflug imaging to distinguish between keratoconus and high myopic astigmatism has not been thoroughly examined.

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Assiut, Egypt, 71515
        • Assiut University
    • Asyut
      • Assiut, Asyut, Egypt, 71526
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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 .

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
keratoconic group
patients with keratoconus

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 group
patients with high myopic astigmatism

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall corneal mean difference thickness between keratoconus and mopc astigmatism
Time Frame: baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Momen Aly, lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • pentacam parameters compare

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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