Clinical Trial: Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

Brief Summary:

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.

Detailed Summary:

Status post Peripheral Laser Iridotomy Beraja Medical Institute has guidelines for the use of steroids after a Peripheral Laser Iridotomy. Patients are normally given prednisolone acetate ophthalmic solution, USP 1.0% to be used four times a day for seven days after the surgery. This protocol will also be used for the Euphrasia drops. This will help us compare the efficacy of the drugs as well as maintain a double blinded study.

Patients will be given blank bottles with only an ID number containing either prednisolone acetate or the Euphrasia eye drop. Bottles will be numbered sequentially by the Larkin Community Hospital pharmacy resident once the drops have been transferred by her and records of which bottles contain which drops will then be stored on the local intranet.

Patients will be given the exact same instructions as well as the instruction to come in/call the on-call resident immediately if there are any adverse side effects, and explained that the most common of which are expected to be signs of inflammation or allergy to the medication. The symptoms that the patients will be advised to call in for will be: redness, swelling, burning or itching lasting more than a few minutes, decrease/loss of vision lasting more than a few minutes. The phone number for the on-call resident is in the consent form. The patient will be given another copy of the consent form, if they do not have it, with the phone number of the on-call resident highlighted.

Patients will be followed up by a resident ophthalmologist on days eight and fifteen post-operatively to measure anterior chamber cell clearing and pain. The resident will only know which number bottle was used, not the drops in the bottleThe resident will also be measuring intraocular pressure, using a Goldman tonometer, and not
Sponsor: Larkin Community Hospital

Current Primary Outcome: Anti-inflammatory [ Time Frame: 15 days post laser ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Side effects [ Time Frame: 15 days post laser ]
  Number of Participants with Adverse Events as a Measure of Safety and Tolerability
• Pain prevention [ Time Frame: 15 days post laser ]
  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)

Original Secondary Outcome: Same as current

Information By: Larkin Community Hospital

Dates:
Date Received: March 26, 2015
Date Started: April 2015
Date Completion:
Last Updated: April 9, 2015
Last Verified: April 2015