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

NCT ID: NCT04054830

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2023-07-31

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

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Topical, preservative-free NSAID

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.

Group Type: EXPERIMENTAL

Voltaren Ophtha 1 mg/ml, GSK

Intervention Type: DRUG

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.

Topical, preservative-free steroid

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.

Group Type: ACTIVE_COMPARATOR

Monopex 1 mg/ml, Théa

Intervention Type: DRUG

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.

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

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 wee

Group Type: EXPERIMENTAL

Voltaren Ophtha 1 mg/ml, GSK

Intervention Type: DRUG

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.

Monopex 1 mg/ml, Théa

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Afrouz Ahmadzadeh

MD, PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniella Bach-Holm, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dpt. of Ophthalmology, Rigshospitalet-Glostrup

Locations

Department of Ophthalmology

Glostrup Municipality, Capital Region, Denmark

Countries

Denmark

References

Ahmadzadeh A, Schmidt BS, Bach-Holm D, Kessel L. Early Inflammation Control After Trabeculectomy by Steroid and Non-steroidal Eye Drops: A Randomized Controlled Trial. Ophthalmol Ther. 2023 Apr;12(2):969-984. doi: 10.1007/s40123-022-00636-2. Epub 2023 Jan 5.

Reference Type: DERIVED

PMID: 36602718 (View on PubMed)

Other Identifiers

EudraCT nr.: 2018-001855-10

Identifier Type: -

Identifier Source: org_study_id