Open Angle Glaucoma Clinical Trial
Official title:
Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.
Background: Trabeculectomy with adjunctive use of Mitomycin C (Trab MMC) is the standard
incisional procedure to lower intraocular pressure (IOP) in adults with open angle glaucoma
(OAG). Trab MMC has been shown to effectively lower IOP, however, it can be associated with
a number of serious complications, such as hypotony maculopathy, choroidal effusion or
hemorrhage, and endophthalmitis, as well as less serious complications that may affect
vision related quality of life such as bleb dysesthesia.
A newer technology, referred to as the Trabectome (NeoMedix Corp., San Juan Capistrano, CA),
removes an arc of trabecular meshwork and inner wall of Schlemm's canal with microcautery
and appears to lower IOP effectively with fewer and less serious complications than Trab
MMC. However, more studies are needed to determine the long term safety and efficacy of this
relatively new procedure.
In addition, for OAG patients with visually significant cataracts, either Trab MMC or
Trabectome can be combined with cataract surgery.
Study Objective: To compare the efficacy and safety of Trabectome versus Trab MMC, in
combination with cataract extraction by phacoemulsification and intraocular lens implant,
for control of IOP in OAG, including pseudoexfoliative glaucoma.
Methods: Single center, single surgeon, prospective randomized controlled trial. A total of
52 eligible participants, 26 per study arm would need to be recruited for 90% power. One eye
per study patient will be enrolled and randomized to Trabectome combined with cataract
surgery (Trabectome-IOL) or Trab MMC combined with cataract surgery (Trab-IOL).
Postoperative visits will take place at the discretion of the surgeon but will include at
least visits at day 1, week 1, and months 1, 3, 6, and 12. Postoperative glaucoma
medications will be added in a stepped regimen as appropriate, along with additional laser
or surgical procedures if needed.
Current Study Status: The clinical trial was terminated early due to slow recruitment and
clearer indications for each technique over time leading to lack of clinical equipoise
essential for patient randomization/recruitment. This had been discussed and agreed upon
with our data safety monitoring board. A total of 19 participants were recruited with
followup to one year. Study analysis is pending.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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