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Electrophysiological Changes in Cases of Different Stages of Keratoconus

Electrophysiological Changes in Cases of Different Stages of Keratoconus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07461129
Enrollment
50
Registered
2026-03-10
Start date
2025-08-20
Completion date
2026-08-20
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

VEP, ERG, Keratoconus

Brief 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.

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

Interventions

None listed

Sponsors

Minia University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Measuring the Amplitude of P2 of Flash visual evoked potential6 monthsMeasuring 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)
Measuring the amplitude of P100 wave in pattern visual evoked potential6 monthsMeasuring 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)
Measuring the Latency of P100 wave of pattern evoked potential6 monthsMeasuring 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)
measuring the latency of P2 wave of Flash visual evoked potential6 monthsMeasuring 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)
Measuring the Amplitude of a wave of Full Field Flash Electroretinography6 monthsMeasuring 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)
measuring the implicit time of a wave of Full Field Flash Electroretinography6 monthsMeasuring 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)
Measuring the amplitude of b wave of Full Field Flash Electroretinography6 monthsMeasuring 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)
Measuring the implicit time of b wave of Full Field Flash Electroretinography6 monthsMeasuring 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)

Countries

Egypt

Contacts

STUDY_CHAIRHossameldin Mohamed Mohamed Moharram, ph.D

Minia university eye hospital

STUDY_DIRECTORMohamed Abdelhamid Mahmoud, Ph.D

Minia university eye hospital

STUDY_DIRECTORAmr Ahmed Mohamed, Ph.D

Minia university eye hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026