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

Last updated: October 25, 2022
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Not Recruiting

Phase

4

Condition

Glaucoma

Treatment

N/A

Clinical Study ID

NCT04054830
EudraCT nr.: 2018-001855-10
  • Ages > 50
  • All Genders

Study 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

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 thepreceding 12 months
  • Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology atRigshospitalet-Glostrup, Denmark
  • Informed consent to participation and ability to comply with study procedures

Exclusion

Exclusion Criteria:

  • Known allergy to any of the contents of the pharmaceuticals (active and in-activeingredients) used in the study
  • Prior intraocular surgery, except from cataract surgery. If cataract surgery has beenperformed, it should at least be 6 months prior to surgery
  • Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angleclosure 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

Study Design

Total Participants: 70
Study Start date:
August 01, 2019
Estimated Completion Date:
July 31, 2023

Connect with a study center

  • Department of Ophthalmology

    Glostrup, Capital Region, 2600
    Denmark

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.