A Phase 2 interventional study of Prostaglandins in Open Angle Glaucoma and Cataract, sponsored by Julie Dawson. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Julie Dawson · Phase 2, Interventional, and Treatment
Post-operative cystoid macular oedema (CMO) is a common complication causing visual loss following routine cataract surgery. This complication is more prevalent in eyes with excessive inflammation as they heal from surgery.
Prostaglandin analogues (PGA) are the commonest first line drugs used in the long-term treatment of primary open angle glaucoma (POAG)- where they reduce the pathologically high pressure in the eye. Prostaglandins are inflammatory mediators.
In the post-operative care of glaucoma patients undergoing cataract surgery, there is a clinical dilemma whether to stop or continue the use of prostaglandin eye drops. Clinical practice is completely dichotomized between continuing and stopping PGA treatment in the postoperative period. There is conflicting scientific literature on the effect of PGA on the incidence of CMO; and only a single randomized control trial (Miyake K, Arch Ophthalmol 1999, 117:34-40), where the post operative regime is not applicable to present practice, compared the incidence of CMO following routine cataract surgery in POAG on PGA.
This study aims to answer the common clinical question of whether or not to stop PGA after routine cataract surgery. Cataract surgery is the commonest operation performed on the NHS and the prevalence of glaucoma is 5% in the population over 80 years old. Thus the clinical dilemma is a common one.
A current literature search reveals that a divided opinion over whether PGAs do increase the incidence of CMO. No study has yet established a causal relationship between the use of PGAs and the development of CMO. Anecdotal reports and small case series have associated peri-operative PGA use with the occurrence of CMO (Henderson BA et al, 2007 J Cataract Refract Surg 33:1550-1558; Moroi SE et al, 1999, Ophthalmology 106:1024-1029). Whilst, in direct contrast, other authors argue CMO as a rare phenomenon and the causative relationship is debated (Schumer RA et al 2000, Curr Opin Ophthalmol 11:94-100; Miyake K et al 2003 J Cataract Refract Surg 29:1800-1810)
The most similar previous study to the one proposed, was by Miyake K et al. (Arch Ophthalmol 1999, 117:34-40). The key difference, though, is in the postoperative drop regime of fluorometholone and diclofenac in that paper and current UK clinical practice of using dexamethasone. In terms of study design, this paper used an invasive method of investigating CMO by fundus fluorescein angiography compared to OCT proposed here.
A recent case report by Agange N \& Mosaed S (Journal of Ophthalmology, 2010) concludes with 'conclusions about causal relationships cannot be made without well-designed, prospective clinical trials addressing this issue'.
This study will therefore use drops that are routinely used in current UK clinical practice and add to the body of evidence that helps answer the question should PGAs be continued after cataract surgery so as to prevent the progression of glaucoma in patients.
Aim
Design
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Julie Dawson is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with advanced glaucoma
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stop prostaglandin eye drops post operatively. Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost
Drug: Prostaglandins
Continue prostaglandin eye drops post operatively Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost
Drug: Prostaglandins
Also known as: Latanoprost Travaprost Bimatoprost Tafluprost
Occurrence of cystoid macula oedema (CMO) at 4 weeks post operatively
Occurrence of cystoid macula oedema (CMO) at 4 weeks post operatively.Cystoid macular oedema will be defined as an increase in the central macula thickness on the OCT with characteristic intraretinal changes in the 4 weeks following surgery.
Time frame: 4 weeks post operatively
Intraocular pressure (IOP) at 4 weeks post-operatively.
Intraocular pressure (IOP) at 4 weeks post-operatively. Intraocular pressure will be measured by Goldmann applanation tonometry, the standard method used in clinical practice to monitor glaucoma. This forms part of the standard post-operative examination following surgery.
Time frame: 4 weeks post operatively
Plan to share: Undecided
Ran from Dec 2016 to primary completion in Oct 2019, 34 months.
Of 41 phase 2 interventional studies under Glaucoma, Open-Angle, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 18. This study's 34 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prostaglandins
Julie Dawson