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

Glaucoma, Open Angle Clinical Trial

— BCATS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114073
• Other study ID #: MUMS-911251
• Secondary ID: IRCT138706111154
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2014
• Last updated: April 17, 2015
• Start date: April 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open Angle
• Glaucoma, Open-Angle

Intervention

Drug:
• Cyclosporine
In study arm, ophthalmic emulsion of cyclosporine A 2% will be prescribed in postoperative phase.
• Betamethasone
In control arm, betamethasone eye drop will be prescribed in postoperative period.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Khatam Eye Hospital	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	Each month following trabeculectomy, intraocular pressure will be measured using Goldmann Applanation Tonometer.	Up to 6 months after surgery	Yes
Primary	Bleb morphology	Bleb morphology according to IBAGS grading system, based on clinical examination and slit-lamp photography.	Up to 6 months after surgery	No
Primary	Subjective dry eye symptoms	Subjective symptoms of dry eye, reported by patients, and gathered using a standardized questionnaire.	Up to 6 months after surgery	No
Secondary	Surgical success rate	The surgical success rate of trabeculectomy in each study arm.	6 month after surgery	Yes
Secondary	Complications	Any complication observed during study period, reported by patient or examiner.	Up to 6 months after surgery	Yes
Secondary	Visual acuity	LogMAR visual acuity, measured on every postoperative visit.	Up to 6 months after surgery	Yes