Medically uncontrolled glaucoma that requires filtration surgery. MedDRA version: 20.0 Level: LLT Classification code 10018326 Term: Glaucoma NOS System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Voltaren Ophtha
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: Diclofenac
Other descriptive name: DICLOFENAC
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
Department of Ophtalmology, Rigshospitalet-Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA •Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) and 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 •Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study •Informed consent to participation and ability to comply with study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 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 •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 who are excluded due to perioperative complications will not provide data for the study. •Patients in systemic treatment with steroid or NSAID
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this 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 or a combination of the two and to explore the mechanisms behind the pathophysiology of glaucoma. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.;Timepoint(s) of evaluation of this end point: 12 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •postoperative intraocular pressure at 24 months, •best corrected visual acuity (logMAR) at 12 and 24 months, •changes in visual field at 12 and 24 months, •optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL) by peripapillary optical coherence tomography (OCT) at 12 and 24 months •lens evaluation at, 12- and 24 months by pentacam •bleb morphology at 12 and 24 months •surgical success at 12 and 24 months. ;Timepoint(s) of evaluation of this end point: 12 months: best corrected visual acuity (logMAR), changes in visual field, optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL), lens evaluation, bleb morphology, surgical success 24 months: postoperative intraocular pressure, best corrected visual acuity (logMAR), changes in visual field, optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL), lens evaluation, bleb morphology, surgical success | — |
Countries
Denmark
Contacts
Public ContactDepartment of Ophtalmology, Ø44
Department of Ophtalmology, Rigshospitalet-Glostrup
Outcome results
None listed