Astigmatism in Keratoconus Patients

NCT ID: NCT03450213

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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 .

Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patients with keratoconus

Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex.

Group Type ACTIVE_COMPARATOR

Pentacam

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

Pentacam

Intervention Type DEVICE

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

Interventions

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Pentacam

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Mamdouh

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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

Reference Type BACKGROUND
PMID: 9493273 (View on PubMed)

Other Identifiers

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Keratoconus

Identifier Type: -

Identifier Source: org_study_id

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