Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

NCT02416128 | Withdrawn

• 1 other identifier: LCH-4-012015
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Side effects

  15 days post laser

• Pain prevention

  15 days post laser

Study Arms (2)

Iritis prevention after LPI: prednisolone

ACTIVE COMPARATOR

To use prednisolone acetate after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 2.

Drug: Prednisolone acetate

Iritis prevention after LPI: euphrasia

EXPERIMENTAL

To use euphrasia after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 1.

Drug: Euphrasia

Interventions

Euphrasia DRUG

1 drop in the treated eye QID X 10 days

Also known as: Eyebright

Iritis prevention after LPI: euphrasia

Prednisolone acetate DRUG

1 drop in the treated eye QID X 10 days

Also known as: Pred Forte

Iritis prevention after LPI: prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing Peripheral Laser Iridotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Larkin Community Hospital: lead
• Nova Southeastern University: collaborator

Related Publications (4)

• 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.

  PMID: 14078870 RESULT

• BECKER B, MILLS DW. CORTICOSTEROIDS AND INTRAOCULAR PRESSURE. Arch Ophthalmol. 1963 Oct;70:500-7. doi: 10.1001/archopht.1963.00960050502012. No abstract available.

  PMID: 14078872 RESULT

• 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(84)34160-4.

  PMID: 6514289 RESULT

• 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.

  PMID: 11152054 RESULT

Related Links

• Congdon NG, Schein OD, von Kulajta P, Lubomski LH, Gilbert D , Katz J. "Corneal Complications Associated with Topical Ophthalmic Use of Nonsteroidal Antiinflammatory Drugs." Journal of Cataract Refractive Surgery. 2001 ;27(4):622- 631.
• Cullne, K., Golosinkiy, A. "Ambulatory Surgery in the United States, 2006." National Health Statistics Report Number 11, Revised September 4, 2009.
• Shields MB. Textbook of Glaucoma. 4th ed. Philadelphia: Williams \& Wilkins; 2000 .
• SBL's Euphrasia 10% Eye Drops
• Toelg, Michael. "Euphrasia D3 Eye Drops in Children."
• White, L., Foster, S. The Herbal Drugstore. Penguin Group, 2002.

MeSH Terms

Conditions

Iritis

Interventions

euphrasiae herba; prednisolone acetate

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Uveitis, Anterior; Panuveitis; Uveitis

Study Officials

• Austin Bach, DO

  Larkin Community Hospital/Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 14, 2015
• Study Start: April 30, 2015
• Primary Completion: March 25, 2016
• Study Completion: March 25, 2016
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share