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Not yet recruitingNCT06739018Updated Dec 18, 2024

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

An observational study in Keratoconus and High Myopia, sponsored by Assiut University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
66
Ages
15 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Keratoconus
  • High Myopia

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In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 66 is below the median of 130 across 97 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
All
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 .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
66 participants (estimated)
Patient registry
No

Groups and cohorts

  • keratoconic group

    patients with keratoconus

    Other: pentacam scheimpflug tomography

  • high myopic astigmatim group

    patients with high myopic astigmatism

    Other: pentacam scheimpflug tomography

Interventions

  • Otherpentacam scheimpflug tomography

    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.

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What researchers measure

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

    Time frame: baseline

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Study locations

2 sites
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References and documents

Publications

  • 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. PubMed 34855828 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2024; primary completion for Oct 2025, 10 months later.

Of 33 non-industry observational studies under Keratoconus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 204. This study's planned 10 months is below that.

Counting every sponsor, half of 36 studies reached it within 30 months; a quarter within 13 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2024
First posted
Dec 18, 2024
StartEst.
Dec 2024
Primary completionEst.
Oct 2025
CompletionEst.
Oct 2025
Last update
Dec 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06739018
Lead sponsor
Assiut University
Responsible party
Youstena Saied Waheb (DR, Assiut University) — Principal investigator
First posted
Dec 18, 2024
Start date
Dec 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Dec 18, 2024

Study contacts

youstena w saied, resident
Contact
youstenasaied@gmail.com
02+01229887036
Mohamed s abdalrahman, professor
Contact
mohamed66saad@gmail.com
+201222414233
Momen Aly, lecturer
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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