Minimally Invasive Glaucoma Surgery: 12-Month Outcomes Of Kahook Dual Blade – Goniotomy As A Stand-Alone Procedure Or Combined With Cataract Surgery In Open-Angle Glaucoma

To evaluate the efficacy and safety profile of excisional goniotomy performed with Kahook Dual Blade in patients with open-angle glaucoma as a stand-alone procedure as well as in combination with phacoemulsification over 12-month period.

 

A prospective, single-centered, longitudinal interventional study in adult patients with postoperative follow-up over a period of 12 months.

 

 

 

Study Type:Interventional

Actual Enrollment:15 participants(16 eyes)

Allocation:non-randomized

Interventional model:Parallel Assignment. First group recieved goniotomy performed with Kahook Dual Blade combined with phacoemulsification; second group recieved goniotomy with Kahook Dual Blade as a standalone procedure 

Masking:unmasked

Primery Purpose:Treatment

Primery goals: Evaluation of  IOP and medication - lowering effect of the procedure in the 2 groups and the total patient population.

Secondary goals: To analyze the safety profile - the complications rate, the need of additional antiglaucoma procedures; the stability of the therapeutic effect (based on variations of IOP at each visit); the success rate and differences between the two groups

An average reduction of IOP with 12.81 mmHg (44.59%) was observed in the total population of patients. The first group has shown mean IOP-reduction of 12.75 mmHg(44.34 %), while the second one : 12.87 ± 6.55 mmHg(44.83%).  

The average medication number reduction was 1.75 (39.68%) for all the enrolled patients; with 1.37( 31.87%) medications for the first group and 2.12 (47.5%) for the second one. The most common intraoperative complication was blood reflux from Schlem's canal (100% of patients); the most common early postoperative complication - transient hyphema (resolved within 7 days) - in 43.75%, and late postoperative complication - posterior vitreous detachment( 6.25%)

The observed IOP - lowering effect of combined phacoemulsification-KDB-goniotomy procedure as well as the standalone KDB-goniotomy meet the European Glaucoma Society and the American Academy of Ophthalmology's (PPP) Preferred Practice Pattern effectiveness criteria for mild to moderate glaucoma.

No vision threatening complications were found and no additional antiglaucoma procedure were required during the 12-month of follow-up