Iritis Clinical Trial
Official title:
Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology
Verified date | October 2023 |
Source | Larkin Community Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators plan to use an herbal eye drop, Euphrasia, aka Eyebright, for post-operative inflammation for Peripheral Laser Iridotomy for the treatment of narrow angle glaucoma. A peripheral Laser Iridotomy is a simple laser procedure with few complications if the patient follows the post-operative instructions. In this procedure, a blue-green Argon laser is used to create an orifice in the iris to open the angle by allowing the aqueous from behind the iris to enter the anterior chamber. Rarely the procedure needs to be repeated. The main complications from this surgery are postoperative inflammation, bleeding, and postoperative pressure spikes. The investigators will be using Weleda's Euphrasia D3 eye drops. The investigators plan to do a double blinded randomized control trial to objectively measure ocular inflammation in the same process that was used for the steroid eye drops that are currently out on the market. Some patients will be receiving steroids, prednisolone acetate, others, the herbal eye drop.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 25, 2016 |
Est. primary completion date | March 25, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing Peripheral Laser Iridotomy Exclusion Criteria: - Patients who have had an allergic reaction to Euphrasia (this will be asked to the patient at time of ) - Patients who have had an adverse reaction to steroids (obtained by chart review to determine safety of drop use) - Patients who have inflammation before the LPI (Noted by seeing cell in the anterior chamber) - Patients who had any complications during their cataract surgery (obtained by chart review to determine safety of procedure) - Patients in whom more than 1500mW of energy was used during the Peripheral Laser Iridotomy - Patients in whom the laser was used more than 130 times during the Peripheral Laser Iridotomy |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Larkin Community Hospital | Nova Southeastern University |
ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. I. THE EFFECT OF DEXAMETHASONE IN THE NORMAL EYE. Arch Ophthalmol. 1963 Oct;70:482-91. doi: 10.1001/archopht.1963.00960050484010. No abstract available. — View Citation
BECKER B, MILLS DW. CORTICOSTEROIDS AND INTRAOCULAR PRESSURE. Arch Ophthalmol. 1963 Oct;70:500-7. doi: 10.1001/archopht.1963.00960050502012. No abstract available. — View Citation
Foster CS, Forstot SL, Wilson LA. Mortality rate in rheumatoid arthritis patients developing necrotizing scleritis or peripheral ulcerative keratitis. Effects of systemic immunosuppression. Ophthalmology. 1984 Oct;91(10):1253-63. doi: 10.1016/s0161-6420(8 — View Citation
Stoss M, Michels C, Peter E, Beutke R, Gorter RW. Prospective cohort trial of Euphrasia single-dose eye drops in conjunctivitis. J Altern Complement Med. 2000 Dec;6(6):499-508. doi: 10.1089/acm.2000.6.499. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-inflammatory | Quantitative amount of cell in the anterior chamber (0-5) Measurement of cell in the anterior chamber: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = >50 cells (based on studies used to assess efficacy of other topical steroids) | 15 days post laser | |
Secondary | Side effects | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 15 days post laser | |
Secondary | Pain prevention | Pain assessment: Yes or No pain Pain will be measured as quantitative (Yes/No) (based on studies used to assess efficacy of other topical steroids) | 15 days post laser |
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---|---|---|---|
Completed |
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