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

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ClinicalTrials.gov Identifier: NCT02114073
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Ramin Daneshvar, MD, Mashhad University of Medical Sciences

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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 Name: 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 Name: Betasonate (Sina Darou)


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: Up to 6 months after surgery ]
    Each month following trabeculectomy, intraocular pressure will be measured using Goldmann Applanation Tonometer.

  2. Bleb morphology [ Time Frame: Up to 6 months after surgery ]
    Bleb morphology according to IBAGS grading system, based on clinical examination and slit-lamp photography.

  3. Subjective dry eye symptoms [ Time Frame: Up to 6 months after surgery ]
    Subjective symptoms of dry eye, reported by patients, and gathered using a standardized questionnaire.


Secondary Outcome Measures :
  1. Surgical success rate [ Time Frame: 6 month after surgery ]
    The surgical success rate of trabeculectomy in each study arm.

  2. Complications [ Time Frame: Up to 6 months after surgery ]
    Any complication observed during study period, reported by patient or examiner.

  3. Visual acuity [ Time Frame: Up to 6 months after surgery ]
    LogMAR visual acuity, measured on every postoperative visit.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114073


Locations
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Iran, Islamic Republic of
Khatam Eye Hospital
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91959-61151
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
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Principal Investigator: Ramin Daneshvar, MD, MSc Eye Research Center, Cornea Research Center, Mashhad University of Medical Sciences
More Information
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Responsible Party: Ramin Daneshvar, MD, Dr. Ramin Daneshvar, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02114073    
Other Study ID Numbers: MUMS-911251
IRCT138706111154N1 ( Other Identifier: Iranian Registery of Clinical Trial )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by Ramin Daneshvar, MD, Mashhad University of Medical Sciences:
glaucoma
trabeculectomy
cyclosporine
betamethasone
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Cyclosporine
Betamethasone
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents