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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical, preservative-free NSAID | Experimental | 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. |
|
| Topical, preservative-free steroid | Active Comparator | 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. |
|
| Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voltaren Ophtha 1 mg/ml, GSK | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | Postoperative intraocular pressure (IOP) by applanation tonometry | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR) | 12 months, 24 months |
| Visual field | Postoperative changes in visual field by octopus autoperimetry. (MD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniella Bach-Holm, MD, Ph.D. | Dpt. of Ophthalmology, Rigshospitalet-Glostrup | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology | Glostrup Municipality | Capital Region | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36602718 | Derived | 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. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| C023768 | halofantrine |
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|
| Monopex 1 mg/ml, Théa | 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. |
|
| 12 months, 24 months |
| Optical nerve damage | Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT) | 12 months, 24 months |
| Surgical success | The definition of surgical success criteria is dependent on the the severity of visual field defect (MD, mean deviation of visual sensitivity compared to those expected from the age-matched normative database) glaucoma diagnosis and achievement of target pressure without the use of medication (complete success) or with the use of glaucoma medication (qualified success)
| 12 months, 24 months |