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Active, not recruitingNCT07461129Updated Mar 11, 2026

Electrophysiological Changes in Cases of Different Stages of Keratoconus

An observational study in Keratoconus, sponsored by Minia University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Minia University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 40 Years
Sex
All
01

Study summary

Keratoconus is a bilateral and asymmetric disease which results in progressive thinning and steeping of the cornea leading to irregular astigmatism and decreased visual acuity.A typical patient with keratoconus presents in the teens or early twenties with complaints of blurring or distortion in vision and having to change glasses frequently due to changes in refractive error.

Corneal thinning frequently precedes ectasia. In moderate and advance cases, a hemosiderin arc or circle line, known as Fleischer's ring, is frequently seen around the cone base. Vogt's striaes, which are fine vertical lines produced by Descemet's membrane compression, is another characteristic sign. Most patients eventually develop corneal scarring. Munson's sign, a V-shape deformation of the lower eyelid in downward position; Rizzuti's sign, a bright reflection from the nasal area of the limbus when light is directed to the limbus temporal area; and breakages in Descemet's membrane causing acute stromal oedema, known as hydrops, are observed in advanced stages.

Corneal blindness is one of the major causes of reversible blindness, which can be managed with transplantation of a healthy donor cornea. It is the most successful organ transplantation in the human body as cornea is devoid of vasculature, minimizing the risk of graft rejection.

Preoperative clinical evaluation of visual potential after corneal transplantation in the patient with dense corneal opacity remains difficult using only history and biomicroscopic examination. Some studies found that electrophysiologic tests were good predictors of visual prognosis prior to corneal transplantation.

Electrophysiology is an objective functional test of the visual pathway and allows the location of visual dysfunctions to be detected. Full-field electroretinography (ERG) is an established clinical technique used to evoke and record mass responses of the retina to flashes of light. The ISCEV Standard full-field ERGs assess generalized retinal function under dark-adapted (DA) and light-adapted (LA) conditions.The visual evoked potential (VEP) is a cortical response and serves as a functional test of the entire visual pathway from the eye to the visual system of the brain.

Read the detailed description

Aim of the Study To assess the effect of different stages of keratoconus on electrophysiology test results.

All patients will undergo a comprehensive ocular examination including:

  1. Best corrected visual acuity (BCVA).
  2. Anterior segment examination using slit lamp bio microscopy.
  3. Posterior segment examination using a +78 D condensing lens and peripheral retinal examination by means of binocular indirect ophthalmoscopy (keeler ophthalmoscope).
  4. Penatacam examination to define grade of KC and corneal topography.
  5. OCT-ONH to assess the function of optic nerve. 6-Electrophysiological tests:

All subjects will be examined using:

  1. FVEP: via the assessment of the amplitude \&latency of P2 wave
  2. PVEP:via the assessment of the amplitude \&latency of P100 wave 3- Full field flash ERG: via the assessment of the amplitude \& implicit time of a\&b waves
02

Conditions studied

  • Keratoconus

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Keywords

  • VEP
  • ERG
  • Keratoconus
03

In context

Keratoconus

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

This study's planned enrollment of 50 is below the median of 130 across 94 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Study participants will be : from 18 to 40 years old:

50 eyes of control patients 50 eyes of patients who had KC

Inclusion criteria

  • Patients aged from 18 to 40 years with keratoconus of different stages

Exclusion criteria

Exclusion criteria:

  • Keratoconus Patients with any prior history of ocular procedures.
  • Patients with dense cataract.
  • Patients with retinal , vitreous problems or uveiitis .
  • Patients with optic nerve pathology
  • History of ocular medications e.g antiglaucoma
  • History of previous ocular surgery
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Keratoconus group

    Patients with different stages of keratoconus

  • Normal

    patients whose pentacam doesn't show any keratoconus findings or any other abnormalities

06

What researchers measure

Primary outcomes

  1. Measuring the amplitude of P100 wave in pattern visual evoked potential

    Measuring the amplitude of P100 wave of pattern visual evoked potential in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

  2. Measuring the Latency of P100 wave of pattern evoked potential

    Measuring the latency of P100 wave of pattern visual evoked potential in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

  3. Measuring the Amplitude of P2 of Flash visual evoked potential

    Measuring the amplitude of P2 wave of Flash visual evoked potential in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

  4. measuring the latency of P2 wave of Flash visual evoked potential

    Measuring the latency of P2 wave of Flash visual evoked potential in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

  5. Measuring the Amplitude of a wave of Full Field Flash Electroretinography

    Measuring the amplitude of a wave of full field flash ERG in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

  6. measuring the implicit time of a wave of Full Field Flash Electroretinography

    Measuring the Implicit time of a wave of full field flash ERG in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

  7. Measuring the amplitude of b wave of Full Field Flash Electroretinography

    Measuring the amplitude of b wave of full field flash ERG in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

  8. Measuring the implicit time of b wave of Full Field Flash Electroretinography

    Measuring the implicit time of b wave of full field flash ERG in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

    Time frame: 6 months

07

Study locations

1 site
  • Minia university eye hospital
    Minya, Minya Governorate 61512, Egypt
08

References and documents

Publications

  • google scholar

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07461129
Lead sponsor
Minia University
Responsible party
Alaa Mohamed Riad Qassem (MD, Minia University) — Principal investigator
First posted
Mar 10, 2026
Start date
Aug 20, 2025
Primary completion
Jun 20, 2026 (estimated)
Completion
Aug 20, 2026 (estimated)
Last update
Mar 11, 2026

Study contacts

Hossameldin Mohamed Mohamed Moharram, ph.D
study chair · Minia university eye hospital
Mohamed Abdelhamid Mahmoud, Ph.D
study director · Minia university eye hospital
Amr Ahmed Mohamed, Ph.D
study director · Minia university eye hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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