Meibomian Gland Dysfunction
Conditions
Brief summary
In this randomized clinical trial, patients with Meibomian gland dysfunction aged 50 year and more will be enrolled. The Meibomian gland dysfunction diagnosis will confirmed by a cornea specialist. The enrolled patients will be randomly allocated to the treatment and placebo group. The patients in treatment group will receive topical vitamin D every 6 hours daily (25 Microgram/cc or 1000 IU). The control group will receive the same-shape packed drop without vitamin D. The patients in both group will receive the conventional treatment including hot compress and shampoo scrub. The primary outcome is the change in Ocular surface disease index and 5-Item Dry Eye Questionnaire score assessed before the topical treatment and every one-months until 3 months. The secondary outcome measures are Tear breakup time, Schirmer test, Corneal fluorescein staining, Meibomian gland expressibility. The grader and the patients will blind to the study group.
Interventions
DRUGTopical Vitamin D eye drop
25 Microgram/cc or 1000 IU
DRUGTopical placebo eye drop
The same-shape packed drop without vitamin D
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.
Exclusion criteria
* Patients with Vitamin D deficiency * Patients taking Vitamin D systemic Supplementation * Patient with prior ocular surgeries within previous 6 months. * Patient with other causes of dry eye, such as aqueous tear deficiency or ocular surface disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index score | 3 months | The standard questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear breakup time (TBUT) | 3 months | time between fluorescein staining of the cul de sac and appearing dry island on the cornea |
| schirmer1 | 3 months | Millimeter of the standard strip wetting by tear of the patient |
| Fluorescein staining test | 3 months | The number of fluorescein stained points on the cornea & conjunctiva based on Oxford classification score |
Countries
Iran
Outcome results
None listed