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

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02114073

Collaborator

(none)

Enrollment

Location

Arms

10.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open Angle	Drug: Cyclosporine Drug: Betamethasone	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclosporine 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.	Drug: Cyclosporine In study arm, ophthalmic emulsion of cyclosporine A 2% will be prescribed in postoperative phase. Other Names: Cyclosporine A (Sina Darou)
Active Comparator: Betamethasone 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.	Drug: Betamethasone In control arm, betamethasone eye drop will be prescribed in postoperative period. Other Names: Betasonate (Sina Darou)

Arm

Intervention/Treatment

Experimental: Cyclosporine

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.

Drug: Cyclosporine

In study arm, ophthalmic emulsion of cyclosporine A 2% will be prescribed in postoperative phase.

Other Names:

Cyclosporine A (Sina Darou)

Active Comparator: Betamethasone

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.

Drug: Betamethasone

In control arm, betamethasone eye drop will be prescribed in postoperative period.

Other Names:

Betasonate (Sina Darou)

Outcome Measures

Primary Outcome Measures

Intraocular Pressure (IOP) [Up to 6 months after surgery]
Each month following trabeculectomy, intraocular pressure will be measured using Goldmann Applanation Tonometer.
Bleb morphology [Up to 6 months after surgery]
Bleb morphology according to IBAGS grading system, based on clinical examination and slit-lamp photography.
Subjective dry eye symptoms [Up to 6 months after surgery]
Subjective symptoms of dry eye, reported by patients, and gathered using a standardized questionnaire.

Secondary Outcome Measures

Surgical success rate [6 month after surgery]
The surgical success rate of trabeculectomy in each study arm.
Complications [Up to 6 months after surgery]
Any complication observed during study period, reported by patient or examiner.
Visual acuity [Up to 6 months after surgery]
LogMAR visual acuity, measured on every postoperative visit.