Astigmatism in Keratoconus Patients

Overview

Keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. It manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment.

Full Title of Study: “Comparison of Anterior and Posterior Corneal Astigmatism in Patients With Keratoconus and Controls”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2020

Detailed Description

Keratoconus is the most common form of corneal ectasia, with an incidence of 50-230 per 100,000 persons.Pentacam used diagnose & detect the progression in patients with keratoconus and also provide a detailed information about corneal tomography and topography. In the last few years, it has been shown that in healthy individuals the posterior corneal surface has not only a different amount of astigmatism but also a different alignment of the steep meridian. The aim of this research is to compare the amount and axis alignment of anterior and posterior corneal astigmatism in keratoconus with a healthy controlled group .

Interventions

  • Device: Pentacam
    • Pentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism.

Arms, Groups and Cohorts

  • Active Comparator: Patients with keratoconus
    • Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex.
  • Placebo Comparator: Normal people at the same age and sex
    • Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex.

Clinical Trial Outcome Measures

Primary Measures

  • Comparison between astigmatism in patients with keratoconus and normal people.
    • Time Frame: Two years
    • Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex

Participating in This Clinical Trial

Inclusion Criteria

  • Patients diagnosed with keratoconus using the following criteria: Specific diagnostic signs is asymmetric refractive errors with high progressive or irregular astigmatism, and elevated keratometry values, scissoring of the red reflex, Vogt striae, Fleischer rings, inferior or central steepening on topography with abnormal localized steepening . Exclusion Criteria:

  • Unwillingness to participate in the study . – Corneal scarring. – Any ectatic conditions that were not explicitly keratoconus such as keratoglobus and pellucid marginal degeneration . – Previous ocular surgery.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Doaa Mamdouh, Principal investigator – Assiut University

References

Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.