Corneal Topographic Changes in Different Grades of OSA

NCT ID: NCT06347900

Last Updated: 2025-05-02

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-30

Brief Summary

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Corneal topographic parameters in different degrees of obstructive sleep apnea

Detailed Description

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Obstructive sleep apnea (OSA) syndrome is a disease characterized by recurrent total or partial upper airway collapse during sleep, interrupting or reducing the airflow, and after ward resulting in temporary awakening which causes restoration of flow of the upper airway. These intermittent complete (apnea) or partial (hypopnea) respiratory cessations decrease blood oxygen levels (hypoxia).

Upper airway stenosis causes hypoxemia and hypercapnia, which can lead to multiple organ dysfunction and is associated with systemic diseases, such as hypertension, diabetes, and coronary arteriosclerosis, and changes in the eyes include floppy eyelid syndrome, keratoconus, and glaucoma.

The prevalence of OSA is between 2% and 10% in females and 4-20% in males and obesity is a major risk factor for the development of OSA.

With all the adverse effects associated with OSA, its secondary effects cause several ocular complications. Previous studies have shown that OSA is associated with increased risks of several vision-threatening and nonthreatening ocular disorders, including senile cataracts, normal-tension glaucoma, retinal ischemia, conjunctival hyperemia, and dry eye.

Several contributory mechanisms to the ocular complications of OSA have been reported, including intermittent hypoxia, oxidative stress, systemic inflammatory responses (such as interleukin-6 (IL-6), IL-8, tumor necrosis factor-alpha (TNF-α), C-Reactive protein (CRP), matrix metalloproteinase 9 (MMP-9), vascular cell adhesion molecule (VCAM), intercellular adhesion molecule (ICAM), selectins), sympathetic system overaction, damage effects of endothelin-1, and disruption of the blood-retinal barrier (BRB) (6-8). There are limited publications that manipulate the corneal topographic parameters in different degrees of OSA, especially in the Egyptian population.

Conditions

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Corneal Ectasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group (Group1)

Normal control subjects

Pentacam (corneal topographic changes detection), Polysymnography

Intervention Type DIAGNOSTIC_TEST

Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Mild OSA (Group 2)

Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 5-15

Pentacam (corneal topographic changes detection), Polysymnography

Intervention Type DIAGNOSTIC_TEST

Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Moderate OSA (Group 3)

Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 15-30

Pentacam (corneal topographic changes detection), Polysymnography

Intervention Type DIAGNOSTIC_TEST

Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Sever OSA (Group4)

Cases with mild obstructive sleep apnea (RDI) with respiratory distress index \>30

Pentacam (corneal topographic changes detection), Polysymnography

Intervention Type DIAGNOSTIC_TEST

Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Interventions

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Pentacam (corneal topographic changes detection), Polysymnography

Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with diagnosed OSA

Exclusion Criteria

* Any corneal scars, previous ocular surgeries, patients with keratoconus
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Elshimaa A.Mateen

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elshimaa A.Mateen

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of ophthalmology, Sohag University

Locations

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Ophthalmology department, Sohag University

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-23-09-7PD

Identifier Type: -

Identifier Source: org_study_id

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