Glaucoma, Open Angle Clinical Trial
Official title:
Comparison of Effect of Cyclosporine Ophthalmic Emulsion 2% and Betamethasone Eye Drop on Intraocular Pressure, Conjunctival Hyperemia and Subjective Dry Eye Symptoms Following Trabeculectomy in Open Angle Glaucoma Patients
Glaucoma is one of the leading causes of blindness worldwide and trabeculectomy is the most commonly performed operation to slow-down the disease progression. In this study, we compare the effect of topical cyclosporine A and betamethasone eye drops on the postoperative course and surgical success of trabeculectomy.
Trabeculectomy is still the most popular filtering surgery for glaucomatous patients. In
this type of surgery, postoperative care and management is highly important for surgical
success. A principle component of postoperative regimen is anti-inflammatory medications.
However, corticosteroid eye drops, the most frequently used agents, have some side effects,
including raising intraocular pressure.
Cyclosporine A could be an interesting alternative, because not only it has acceptable
anti-inflammatory effect and could reduce some ocular surface problems, but also it has
minimal direct effect on intraocular pressure. In this study, we will compare the effect of
topical cyclosporine A and betamethasone on surgical outcome and postoperative course of
trabeculectomy patients.
The study is a prospective study to compare the effect of topical betamethasone and
cyclosporine A on postoperative findings of glaucoma patients, undergoing trabeculectomy
surgery.
In this study, trabeculectomy patients, who fulfill the study criteria, will be randomized
to either study group and follow-up visits will be done in a masked fashion. In each visit,
a detailed history taking and eye examination will be done by an examiner unaware of study
group. A third party would do data control for patient safety. At the conclusion of the
study, the data of the two groups would be compared. All human research ethical codes are
strictly respected and the Ethical Committee of the University has an ongoing inspection on
all study steps.
We hypothesize that cyclosporine A could provide better inflammation and intraocular
pressure control and may enhance surgical success rate. However, our null hypothesis is that
the result in study groups will not differ statistically significantly.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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