NCT06288945

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

February 24, 2024

Last Update Submit

February 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 months

Study Arms (2)

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.

Other: Educational Program

Control Group

NO INTERVENTION

The control group was selected first and did not receive the educational program for dry eye syndrome

Interventions

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20 to 60 years old.
  • Alert, and able to communicate.

You may not qualify if:

  • patients with recent ocular surgeries in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Alexandria university

Alexandria, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 34531649BACKGROUND
  • 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.

    PMID: 30366798BACKGROUND
  • Rabie 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.

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 24, 2024

First Posted

March 1, 2024

Study Start

January 15, 2023

Primary Completion

September 14, 2023

Study Completion

September 14, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations