Clinical trial NCT04054830: Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy.
Official title: Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. An Investigator-initiated Randomized Study (The SNAP Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Keywords: Trabeculectomy
NSAID
Steroid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Eye Diseases
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 12 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 12 months, 24 months
measure: Visual field
timeFrame: 12 months, 24 months
measure: Optical nerve damage
timeFrame: 12 months, 24 months
measure: Surgical success
timeFrame: 12 months, 24 months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology
state: Capital Region,
Study officials:
affiliation: Dpt. of Ophthalmology, Rigshospitalet-Glostrup
name: Daniella Bach-Holm, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: