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
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|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Open Angle||Drug: Cyclosporine Drug: Betamethasone||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
In control arm, betamethasone eye drop will be prescribed in postoperative period.
Other Name: Betasonate (Sina Darou)
- Intraocular Pressure (IOP) [ Time Frame: Up to 6 months after surgery ]Each month following trabeculectomy, intraocular pressure will be measured using Goldmann Applanation Tonometer.
- 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.
- 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.
- Surgical success rate [ Time Frame: 6 month after surgery ]The surgical success rate of trabeculectomy in each study arm.
- Complications [ Time Frame: Up to 6 months after surgery ]Any complication observed during study period, reported by patient or examiner.
- Visual acuity [ Time Frame: Up to 6 months after surgery ]LogMAR visual acuity, measured on every postoperative visit.
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|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation.
- Age <20 years
- History of previous ocular surgery in the same eye;
- Candidate for combined surgery;
- Breast feeding;
- Monocular subject;
- Allergy to any topical antiglaucoma medication or cyclosporine
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
|Iran, Islamic Republic of|
|Khatam Eye Hospital|
|Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91959-61151|
|Principal Investigator:||Ramin Daneshvar, MD, MSc||Eye Research Center, Cornea Research Center, Mashhad University of Medical Sciences|
|Responsible Party:||Ramin Daneshvar, MD, Dr. Ramin Daneshvar, Mashhad University of Medical Sciences|
|Other Study ID Numbers:||
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|
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