Clinical trial NCT02114073: Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open Angle
Keywords: glaucoma
trabeculectomy
cyclosporine
betamethasone
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation.

Exclusion Criteria:

* Age \<20 years
* History of previous ocular surgery in the same eye;
* Candidate for combined surgery;
* Pregnancy;
* Breast feeding;
* Monocular subject;
* Allergy to any topical antiglaucoma medication or cyclosporine

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Up to 6 months after surgery
measure: Bleb morphology
timeFrame: Up to 6 months after surgery
measure: Subjective dry eye symptoms
timeFrame: Up to 6 months after surgery
Secondary outcomes:
measure: Surgical success rate
timeFrame: 6 month after surgery
measure: Complications
timeFrame: Up to 6 months after surgery
measure: Visual acuity
timeFrame: Up to 6 months after surgery
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Khatam Eye Hospital
state: Khorasan Razavi
Study officials:
affiliation: Eye Research Center, Cornea Research Center, Mashhad University of Medical Sciences
name: Ramin Daneshvar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: