Lucentis Versus Mitomycin C During Glaucoma Surgery
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2008 |
| End Date: | April 2011 |
Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of
trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing
epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include
late bleb leaks, hypotony and infection.
trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing
epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include
late bleb leaks, hypotony and infection.
This is an open-label, single center trial with two arms for patients who underwent guarded
filtration surgery to control glaucoma. The control will consist of patients randomly
assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard
fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm
will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab
0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the
surgery. No mitomycin C will be applied.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
filtration surgery to control glaucoma. The control will consist of patients randomly
assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard
fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm
will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab
0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the
surgery. No mitomycin C will be applied.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
Inclusion Criteria:
- 18 yrs or older
- patients requiring first time glaucoma filtering surgery
- phakic or pseudophakic
- must provide written informed consent and comply with study assignments
Exclusion Criteria:
- Pregnant, lactation or premenopausal women not using adequate contraception.
- Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle,
penetrating keratoplasty.
- Abnormality preventing reliable applanation tonometry in each eye.
- Current infection or inflammation in either eye.
- Enrolled in another investigational study.
We found this trial at
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