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

NCT ID: NCT02114073

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-02-28

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.

Conditions

Glaucoma, Open Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cyclosporine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

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

Interventions

Cyclosporine

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

Intervention Type: DRUG

Betamethasone

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

Intervention Type: DRUG

Other Intervention Names

Cyclosporine A (Sina Darou); Betasonate (Sina Darou)

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ramin Daneshvar, MD

Dr. Ramin Daneshvar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramin Daneshvar, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Eye Research Center, Cornea Research Center, Mashhad University of Medical Sciences

Locations

Khatam Eye Hospital

Mashhad, Khorasan Razavi, Iran

Countries

Iran

Other Identifiers

IRCT138706111154N1

Identifier Type: OTHER

Identifier Source: secondary_id

MUMS-911251

Identifier Type: -

Identifier Source: org_study_id