Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. (SNAP)

Rigshospitalet

Status and phase

Active, not recruiting

Phase 4

Conditions

Glaucoma

Treatments

Drug: Monopex 1 mg/ml, Théa

Drug: Voltaren Ophtha 1 mg/ml, GSK

Study type

Interventional

Funder types

Other

Identifiers

NCT04054830

EudraCT nr.: 2018-001855-10

Details and patient eligibility

About

PURPOSE:

Glaucoma is the leading cause of non-curable blindness globally. Patients with glaucoma will get a gradual narrowing of the visual fields caused by compression at the optic nerve head due to increased intraocular pressure. Thus the main preventive strategy is to reduce intraocular pressure, initially by eye drops and/or laser treatment but in some patients surgery is warranted. The surgical procedure (trabeculectomy) most widely performed worldwide creates a path from the anterior chamber to the subconjunctival space and thereby lowers the IOP by producing a more efficient drainage of the aqueous humour. Surgical success depends upon controlling post-operative inflammation to ensure a functional drainage. The purpose of this blinded, randomized study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids. Additionally, we want to explore the mechanisms behind the pathophysiology of glaucoma by evaluating retinal and optic nerve head perfusion before and after IOP lowering surgery. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.

MAIN HYPOTHESIS:

NSAIDs and steroids are equally effective in assuring long-term filtering function and controlling IOP after trabeculectomy but may be associated with different risk profiles and bleb morphology
Patients with lower post-operative IOP demonstrate less progression of visual field loss
Trabeculectomy lowers IOP and provides better microcirculation in and oxygenation of inner retinal layers (i.e. ganglion cell layer) and the optic nerve head

Enrollment

70 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) or ocular hypertension
>50 years
Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months
Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark
Informed consent to participation and ability to comply with study procedures

Exclusion criteria

Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
Prior intraocular surgery, except from cataract surgery. If cataract surgery has been performed, it should at least be 6 months prior to surgery
Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma
Steroid responders
Pregnancy
Fertile women, i.e. women who are not menopausal and women who breastfeed
Patients in systemic treatment with steroid or NSAID

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 3 patient groups

Topical, preservative-free NSAID

Experimental group

Description:

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Treatment:

Drug: Voltaren Ophtha 1 mg/ml, GSK

Topical, preservative-free steroid

Active Comparator group

Description:

Treatment:

Drug: Monopex 1 mg/ml, Théa

Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK

Experimental group

Description:

Treatment:

Drug: Voltaren Ophtha 1 mg/ml, GSK