asya in Dry eye
- Conditions
- Health Condition 1: H00-H59- Diseases of the eye and adnexaHealth Condition 2: H049- Disorder of lacrimal system, unspecified
- Registration Number
- CTRI/2023/03/050918
- Lead Sponsor
- CCRAS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patient between 18-70 years of age suffering from Shushkakshipaka (DES) irrespective of sex or religion.
2.Patient having Shushkakshipaka (DES) symptoms â?? feeling of dryness, irritation, foreign body sensation, non specific ocular discomfort and chronically sore eyes, not responding to a variety of drops instilled earlier.
3.Defective blinking such as low blink rate as seen in prolonged computer and mobile phones users.
4.Vitamin A deficiency and other factors affecting ocular surface for example tropical drugs, preservative of contact lens bearers. Ocular surface allergic disease and scarring disorders.
5.Patient ready to give written consent and study till completion only will be selected.
1.Patient not willing for trial.
2.Allergic by patient report.
3.Pregnancy or lactating mother.
4.Current diagnosis of any of the following ocular conditions-
Acute allergic conjunctivitis, infection (bacterial, viral, protozoan or fungal infection of cornea, conjunctiva, lacrimal gland, lacrimal sac or eye lids)
5.Inflammation (retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis and keratitis).
6.History of patient report of ocular herpetic keratitis.
7.Ocular surgery (including cataract surgery) by patient report within six months.
8.Previous LASIK surgery or any other corneal surgery.
9.Use of glaucoma medication or history of filtering surgery for glaucoma.
10.Eye lid abnormalities that affect lid function (blepharospasm, ectropion, entropion, severe trichiasis).
11.Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects prior ocular trauma etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1st, 8th, 15th, 22nd, 29th day <br/ ><br>Timepoint: 4 Weeks
- Secondary Outcome Measures
Name Time Method 1.Visual symptoms- <br/ ><br>2.Conjunctiva- erythematic (bulbar)- <br/ ><br>3.Conjunctiva-oedema (bulbar)- <br/ ><br>4.Conjunctiva- staining- <br/ ><br>5.Cornea- staining- <br/ ><br>6.Corneal tear signs- <br/ ><br>7.Lid- meibomian glands- <br/ ><br>8.Tear film break up time (TBUT)- <br/ ><br>9.Schirmerâ??s score- <br/ ><br> <br/ ><br>Timepoint: 4 weeks