MedTrace Logo

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

NCT04054830 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-10-26

No results posted yet for this 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

Conditions

Interventions

DRUG

Voltaren Ophtha 1 mg/ml, GSK

Voltaren Ophtha 1 mg/ml, eye drops 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.

DRUG

Monopex 1 mg/ml, Théa

Monopex 1 mg/ml, eye drops 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.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Daniella Bach-Holm, MD, Ph.D. · Dpt. of Ophthalmology, Rigshospitalet-Glostrup

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-06-15
Completion
2023-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054830 on ClinicalTrials.gov