Corneal Topographic Changes in Different Grades of OSA

Corneal Topographic Changes in Different Grades of Obstructive Sleep Apnea Syndrome

Corneal topographic parameters in different degrees of obstructive sleep apnea

Study Overview

• Status: Completed
• Conditions: Corneal Ectasia
• Intervention / Treatment: Diagnostic test: Pentacam (corneal topographic changes detection), Polysymnography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Ophthalmology department, Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients above age of 20 with obstructive sleep apnea syndrome with no history of previous ocular surgeries

Description

Inclusion Criteria:

• patients with diagnosed OSA

Exclusion Criteria:

• Any corneal scars, previous ocular surgeries, patients with keratoconus

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group (Group1); Normal control subjects	Diagnostic test: 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.
Mild OSA (Group 2); Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 5-15	Diagnostic test: 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.
Moderate OSA (Group 3); Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 15-30	Diagnostic test: 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.
Sever OSA (Group4); Cases with mild obstructive sleep apnea (RDI) with respiratory distress index >30	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.	Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.	3 monthes

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Elshimaa A.Mateen, Assistant professor of ophthalmology, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: Soh-Med-23-09-7PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No