Dry Eye SyndromeNCT06288945
Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome
A study testing Educational Program in people with Dry Eye Syndrome, run by Alexandria University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Educational Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20 to 60 years old.
- Alert, and able to communicate.
Who cannot join
- patients with recent ocular surgeries in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Dry Eye Syndrome
- Being tested
- Educational Program
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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. Receives: Other: Educational Program |
| Control Group | No intervention | The control group was selected first and did not receive the educational program for dry eye syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start15 Jan 2023
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Rabie, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288945
- Sponsor's protocol ID
- Dry eye syndrome
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34531649Akpek 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.
PubMed 30366798Rabie EAEGA, ElRazkey JY, Ahmed HA. Empowering vision: the impact of nursing-led educational program on patients with dry eye syndrome. BMC Nurs. 2024 Sep 27;23(1):693. doi: 10.1186/s12912-024-02318-9.
PubMed 39334075
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT06288945
- Acronym / sponsor ID
- Dry eye syndrome
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Educational ProgramThe 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. |
| Control Group | No intervention | –The control group was selected first and did not receive the educational program for dry eye syndrome |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20 to 60 years old.
- Alert, and able to communicate.
Key exclusion criteria (1 listed)
- patients with recent ocular surgeries in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational ProgramThe 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. | Other | Study Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 34531649Al-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.
- Background: PubMed 30366798Akpek 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.
- Derived from this study: PubMed 39334075Rabie EAEGA, ElRazkey JY, Ahmed HA. Empowering vision: the impact of nursing-led educational program on patients with dry eye syndrome. BMC Nurs. 2024 Sep 27;23(1):693. doi: 10.1186/s12912-024-02318-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program in people with Dry Eye Syndrome, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288945, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.