Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure (BCATS)

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Glaucoma, Open Angle

Treatments: Drug: Betamethasone; Drug: Cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT02114073

MUMS-911251

IRCT138706111154N1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

Cyclosporine

Experimental group

Description:

In the first postoperative day following a standard, fornix-based trabeculectomy, ophthalmic emulsion of Cyclosporine A, 2%, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients.

Treatment:

Drug: Cyclosporine

Betamethasone

Active Comparator group

Description:

In the first postoperative day following a standard, fornix-based trabeculectomy, betamethasone eye drop, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients.

Treatment:

Drug: Betamethasone