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

Comparing the results of trabeculectomy using Mytomicin c with trabeculectomy using Ologen to decrease intraocular pressure in patients with glaucoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015020620979N1
Enrollment
20
Registered
2016-03-16
Start date
2014-06-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention 1: intervention: Trabeculectomy using Ologen. Intervention 2: control: trabeculectomy using MMC.
Treatment - Surgery
intervention: Trabeculectomy using Ologen
control: trabeculectomy using MMC

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNaveed Nilforushan

Iran University Of Medical Sciences

naveednil@yahoo.com+98 21 6650 9162

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026