Glaucoma, Open Angle Clinical Trial
— BCATSOfficial 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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Khatam Eye Hospital | Mashhad | Khorasan Razavi |
Lead Sponsor | Collaborator |
---|---|
Mashhad University of Medical Sciences |
Iran, Islamic Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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