Back to resultsAstigmatism in Keratoconus Patients
Primary Purpose
Keratoconus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pentacam
Sponsored by
About this trial
This is an interventional screening trial for Keratoconus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Patients with keratoconus
Normal people at the same age and sex
Arm Description
Pentacam will be used for comparison between astigmatism in patients with keratoconus and 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.
Outcomes
Primary Outcome Measures
Comparison between astigmatism in patients with keratoconus and normal people.
Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03450213
Brief Title
Astigmatism in Keratoconus Patients
Official Title
Comparison of Anterior and Posterior Corneal Astigmatism in Patients With Keratoconus and Controls
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with keratoconus
Arm Type
Active Comparator
Arm Description
Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex.
Arm Title
Normal people at the same age and sex
Arm Type
Placebo Comparator
Arm Description
Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex.
Intervention Type
Device
Intervention Name(s)
Pentacam
Intervention Description
Pentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism.
Primary Outcome Measure Information:
Title
Comparison between astigmatism in patients with keratoconus and normal people.
Description
Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex
Time Frame
Two years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
9493273
Citation
Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
Results Reference
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Learn more about this trial
Astigmatism in Keratoconus Patients
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