Corneal Topographic Changes in Different Grades of OSA

April 29, 2025 updated by: Elshimaa A.Mateen, Sohag University

Corneal Topographic Changes in Different Grades of Obstructive Sleep Apnea Syndrome

Corneal topographic parameters in different degrees of obstructive sleep apnea

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.
Time Frame: 3 monthes
Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.
3 monthes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elshimaa A.Mateen, Assistant professor of ophthalmology, Sohag University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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