Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy: 1-Year Results

Area of Science:

• Ophthalmology
• Surgical Innovation
• Glaucoma Management

Background:

• Open-angle glaucoma requires effective surgical interventions to manage intraocular pressure (IOP).
• Trabeculectomy is a standard surgical procedure, while the Ex-PRESS glaucoma shunt offers a less invasive alternative.
• Comparing the efficacy and safety of these two approaches is crucial for optimizing glaucoma treatment.

Purpose of the Study:

• To prospectively compare the efficacy and safety of the Ex-PRESS glaucoma shunt versus standard trabeculectomy in patients with medically uncontrolled open-angle glaucoma.
• To evaluate differences in intraocular pressure (IOP) reduction, success rates, and complication profiles between the two surgical methods.

Main Methods:

• A randomized controlled trial involving 64 patients with open-angle glaucoma randomized to either Ex-PRESS shunt or trabeculectomy, both augmented with mitomycin-C.
• Exclusion criteria included prior ocular surgery (except specific cases), uveitis, and vitreous in the anterior chamber.
• Data on IOP, success rates, surgical time, medication use, visual acuity, and complications were collected over 12 months.

Main Results:

• No statistically significant differences were observed in mean intraocular pressure (IOP) between the Ex-PRESS shunt (11.3±4.5 mm Hg) and trabeculectomy (11.6±4.5 mm Hg) groups at 1 year.
• Complete success rates were similar: 70% for Ex-PRESS versus 57% for trabeculectomy (P=0.28).
• Surgical time, medication requirements, visual acuity, corneal health, and complication rates were comparable between the two groups.

Conclusions:

• The Ex-PRESS glaucoma shunt and standard trabeculectomy exhibit comparable efficacy and safety profiles for managing open-angle glaucoma.
• Neither procedure showed a statistically significant advantage in terms of IOP control, success rates, complications, or bleb morphology.
• Both surgical options are viable for glaucoma management, with similar outcomes observed in this comparative study.