- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06288945
Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome
February 24, 2024 updated by: Emad Rabie, Alexandria University
Dry eye syndrome (DES) is a widespread ocular disease affecting the general population.
It is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms.
Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions
Study Overview
Detailed Description
Dry eye syndrome (DES) is a prevalent chronic, inflammation resulting in eye discomfort, irritation, tiredness, and visual abnormalities that can make it difficult to read, use a computer, drive, or engage in other activities (1).
It represents a set of tears film disorders caused by decreased tears formation or increased tears evaporation; it causes visual symptoms, ocular surface inflammation, and discomfort.
In addition, DES leads to impaired visual function and can negatively affect the outcomes of cataract surgery (2).Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandria, Egypt
- Faculty of Nursing, Alexandria University
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-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age: 20 to 60 years old.
- Alert, and able to communicate.
Exclusion Criteria:
- patients with recent ocular surgeries in the last 3 months
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
The educational nursing interventions were individually administered to each participant in the study group in two sessions which were conducted after the assessment phase on the day of the eye examination at the ophthalmology outpatient clinic and after the diagnosis of dry eye syndrome.
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The educational program included information about definition and causes of Dry eye syndrome (DES), symptoms of DES, diagnostic measures of DES, differentiation between DES and eye allergy, complications of DES, the effect of DES on vision, management of DES, health education about proper eyelid hygiene, proper nutrition to improve the quality of tear film, measures, and precautions to prevent DES such as avoiding exposure to smoke and environmental changes, avoiding prolonged periods in air-conditioned environments; limiting contact lens use to shorter periods, avoiding staring at the computer screen or smartphone for long periods, and taking frequent breaks.
In addition, health education about the importance of compliance with the treatment of DES, and instructions to maintain normal eye and vision in patients with DES.
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No Intervention: Control Group
The control group was selected first and did not receive the educational program for dry eye syndrome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision
Time Frame: 8 months
|
Ocular surface disease index (OSDI) was developed by the Outcomes Research Group at Allergan Inc in 1997 (20).
It is a 12-item questionnaire developed to assess ocular irritation symptoms associated with dry eye syndrome and their effect on functions related to vision.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Al-Mohtaseb Z, Schachter S, Shen Lee B, Garlich J, Trattler W. The Relationship Between Dry Eye Disease and Digital Screen Use. Clin Ophthalmol. 2021 Sep 10;15:3811-3820. doi: 10.2147/OPTH.S321591. eCollection 2021.
- Akpek EK, Amescua G, Farid M, Garcia-Ferrer FJ, Lin A, Rhee MK, Varu DM, Musch DC, Dunn SP, Mah FS; American Academy of Ophthalmology Preferred Practice Pattern Cornea and External Disease Panel. Dry Eye Syndrome Preferred Practice Pattern(R). Ophthalmology. 2019 Jan;126(1):P286-P334. doi: 10.1016/j.ophtha.2018.10.023. Epub 2018 Oct 23. No abstract available.
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)
January 15, 2023
Primary Completion (Actual)
September 14, 2023
Study Completion (Actual)
September 14, 2023
Study Registration Dates
First Submitted
February 24, 2024
First Submitted That Met QC Criteria
February 24, 2024
First Posted (Actual)
March 1, 2024
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 24, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dry eye syndrome
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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