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Dry eye disease is multifactorial, ocular inflammatory condition causing irritation, stinging sensation, uneasiness and blurring. Non-Sjogren syndrome occurs due to absent or dysfunction of lacrimal gland. Fat soluble vitamin D act as an agent against inflammation and its deficiency may result in various inflammatory diseases including dry eye. Purpose of this study is evaluation of vitamin D3 supplementation role in treating non-Sjogren dry eye along with conventional treatment by using artificial tears in patients with hypovitaminosis D. A prospective study was conducted in Rural health center(RHC) Buchal Kalan on 108 patients presenting with non-Sjogren dry eyes and low serum vitamin D levels. Patients were subjected to the following examination; best corrected visual acuity (BCVA), slit-lamp examination, applanation tonometry, fundoscopy, tear breakup time (TBUT) after fluorescein staining, Schirmer tear test, numerical pain rating scale (NPRS) and ocular surface disease index (OSDI) score on day 0, 15, 30, 60 and 90. Vitamin D levels was assessed by electrochemiluminescence immunoassay (ECLIA) based analyzer. The sample was randomly divided into two groups by non-probability purposive sampling. Group 1 received only artificial tears 4times/day while group 2 were given oral vitamin D3 supplementation of 6000 international unit (IU) daily along with artificial tears. Impact of oral vitamin D3 supplementation on non-Sjogren dry eyes was assessed by comparing means of ocular parameters of both groups over different period of time by using Mann-Whitney Test and Friedman Test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Treatment | Active Comparator | Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days. |
|
| Vitamin D3 Supplementation | Experimental | Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | New treatment option for dry eye patients with low serum vitamin D Level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Breakup time in seconds | Improvement after vitamin D3 supplementation over a period of time | 90 days |
| Schirmer test score in millimeters | Improvement after vitamin D3 supplementation over a period of time | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular surface disease index score in units | Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition. | 90 days |
| Numerical Pain Rating Scale | Change in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bushra Kanwal, MPO | The University of Faisalabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RHC Buchal Kalan | Chakwal | Punjab Province | 48800 | Pakistan |
Plan to share results only due to confidentiality
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Artificial tear | Drug | Conventional dry eye treatment |
|
| 90 days |
| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009883 |
| Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |