Dry Eye
Conditions
Keywords
20-20-20 Rule, Artificial Tears, Computer Vision Syndrome, Digital Eye Strain, OSDI, Tear Film, NIBUT
Brief summary
This study is for anyone struggling with dry, tired, or uncomfortable eyes, especially from long hours on screens. We all know that feeling after staring at a laptop or phone too long. This study from Zagazig University looks at a simple habit called the 20-20-20 rule: every 20 minutes, take a 20-second break to look at something about 20 feet away. We want to see if doing this every day, along with your regular artificial tears, helps your eyes feel better than tears alone. If you join, you will use artificial tears as usual. Some participants will also be asked to practice the 20-20-20 rule throughout the day. We will follow you for about 8 weeks and check your symptoms, tear film, and overall eye comfort with simple eye exams and questionnaires. There is no experimental drug involved, just a daily habit we hope will make standard treatment work better. The study was approved by the Institutional Review Board, Faculty of Medicine, Zagazig University on 07-September-2024.
Detailed description
* Study Design:\* Randomized controlled trial, 1 year total, 3 months per participant, at Ophthalmology Department, Zagazig University. * Population:\* 48 IT employees at Zagazig University, age 20-50, digital screen use \>=3 hours/day, mild-to-moderate dry eye. 24 per group. \*Intervention:\* * Group A (Control, n=24): Preservative-free sodium hyaluronate artificial tears (single-dose units), 1 drop in each eye, 4 times daily for 3 months. * Group B (Experimental, n=24): Same artificial tears (same dose/duration) + 20-20-20 rule instructions throughout the workday, reinforced via eye-blink reminder application for 3 months. * Follow-up:\* Baseline, Month 1, Month 2, Month 3. At each visit: OSDI questionnaire and Dry Eye Analyzer SLM-6E(A) assessment including NIBUT, TMH, lipid layer, bulbar redness scan, meibomian gland opening and meibomian gland dysfunction. * Primary Outcome:\* Change in OSDI and NIBUT from baseline to Month 3. * Secondary Outcomes:\* Change in TMH, lipid layer, red scan, meibomian gland parameters. * Sample Size:\* 48 total (24 per group), calculated using OpenEpi with 95% CI and 80% power.
Interventions
1\. Artificial Tears (Drug): for arm 1 Preservative-free sodium hyaluronate ophthalmic solution, 1 drop in each eye 4 times daily for 3 months. Standard lubricating therapy for video display terminal-associated dry eye, given to both arms as background treatment.
BEHAVIORAL20/20/20 rule
Participants are instructed to follow the 20-20-20 rule during all video display terminal use: every 20 minutes of continuous screen work, look at an object at least 20 feet (6 meters) away for at least 20 seconds, accompanied by 5 conscious, complete blinks. To reinforce adherence, participants install an eye-blink reminder application on their phone/work computer that prompts every 20 minutes during work hours. Training on the rule is provided at baseline with a written leaflet. Duration: throughout the 3-month study period, during work hours (approx. 8 hours/day).
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-center, randomized, parallel assignment, open-label study with 2 arms (1:1 allocation). 48 participants are randomized to 24 in Group A (control: preservative-free sodium hyaluronate artificial tears 1 drop in each eye 4 times daily for 3 months) and 24 in Group B (experimental: same artificial tears regimen plus 20-20-20 rule reinforced by eye-blink reminder application during workday for 3 months).
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Age 18 to 45 years, both sexesVideo Display Terminal (VDT) use ≥ 4 hours/day for work/studyDiagnosis of Dry Eye Disease: OSDI score ≥ 13 AND Non-Invasive Keratograph Break-Up Time (NIKBUT) \< 10 seconds on Dry Eye AnalyzerWilling and able to follow the 20-20-20 rule (for Arm 2) and instill artificial tears as instructedSigned informed consent
Exclusion criteria
Active ocular infection, inflammation, allergy, or traumaContact lens wear (current or within 2 weeks)Previous ocular surgery or laser procedureUse of anti-glaucoma medications or topical steroids/NSAIDsSystemic diseases known to cause dry eye (e.g., Sjögren's syndrome, rheumatoid arthritis, SLE)Systemic medications affecting tear secretion (e.g., antihistamines, antidepressants, isotretinoin) - unless stable dose for \>3 monthsPregnancy or lactationParticipation in another clinical trial within 30 days \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months. | Assessed at baseline, 6 weeks, and 3 months | OSDI is a 12-item validated questionnaire scored 0-100, with higher scores indicating more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-Invasive Keratograph Break-Up Time (NIKBUT) | Assessed at baseline, 6 weeks, and 3 months. | First and average NIKBUT in seconds, measured automatically by the Dry Eye Analyzer. |
| Change in Central Lower Tear Meniscus Height (TMH) | Assessed at baseline, 6 weeks, and 3 months. | Central lower tear meniscus height in mm, measured by the Dry Eye Analyzer. |
| Change in Bulbar Conjunctival Redness Score | Assessed at baseline, 6 weeks, and 3 months. | Objective bulbar redness graded 0-4 by the analyzer's automated R-scan. |
| Change in Meibomian Gland Loss | Assessed at baseline, 6 weeks and 3 months | Percentage of meibomian gland loss in upper and lower eyelids assessed by infrared meibography using the analyzer. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAlaa M Saleh, MD
Zagazig University
Outcome results
None listed