Astigmatism in Keratoconus Patients

October 15, 2018 updated by: Doaa Mamdouh, Assiut University

Comparison of Anterior and Posterior Corneal Astigmatism in Patients With Keratoconus and Controls

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Pentacam
Pentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism.
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.
Device: Pentacam
Pentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two years

Collaborators and Investigators

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

Sponsor

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.

General Publications

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 (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Keratoconus

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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