Trabeculectomy with mytomycin c versus trabeculectomy with ologen: clinical results in glaucoma

Phase 3

• Conditions: Condition 1: glaucoma. Condition 2: Primary open-angle glaucoma. Condition 3: Primary angle-closure glaucoma. Condition 4: Glaucoma secondary to other eye disorders. Condition 5: Glaucoma secondary to drugs.; Glaucoma; Primary open-angle glaucoma; Primary angle-closure glaucoma; Glaucoma secondary to other eye disorders; Glaucoma secondary to drugs

• Registration Number: IRCT2015020620979N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients who are known cases of POAG; NTG;JOAG; SOAG;CACG; SACG (glaucomatous optic neuropathy based on the examination and HVF testing), and whose optic nerve function is failing or is likely to fail is already on the maximum tolerated medical therapy and is not likely to achieve a sufficient IOP reduction with laser treatment, or when poor patient compliance is suspected.
Exclusion criteria: A blind eye (VA=LP or NLP); Patients who have extensive conjunctival injury (Trauma, vitreo–retinal surgery, previous glaucoma Surgery and other); Patients who have extremely thin sclera; Patients who have had previously failed filtration procedures; Patients who have secondary glaucomas (uveitic, neovascular); Patients with an allergy to collagen; Patients younger than 18 years of age; Patients with angle-recession or high episcleral venous pressure glaucoma; patients with one eye; pregnancy and breast-feeding; history of any intraocular surgery except for cataract surgery that has been performed more than 6 months before enrollment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percentage change in intraocular pressure from baseline. Timepoint: in day 1,week 1,week 2,month 1,2,3,6 after surgery. Method of measurement: intraocular pressure will be measured by goldman tonometer and percentage change in intraocular pressure from baseline will be measured.

Secondary Outcome Measures

Name	Time	Method
Bleb structure. Timepoint: 6 months. Method of measurement: the Indiana bleb appearance grading scale (IBAGS).;Number of anti-glaucoma medications. Timepoint: 6 months. Method of measurement: counting the number of daily anti-glaucoma medications.;Visual aquity. Timepoint: 6 months. Method of measurement: snellen chart.;Visual field. Timepoint: 6 months. Method of measurement: humphery visual field test.;Complications. Timepoint: 6 months. Method of measurement: clinical examination.;Intraocular pressure. Timepoint: 6 months. Method of measurement: goldman tonometery.