Efficacy and safety of a steel drainage device implanted under a scleral flap.
OBJECTIVE
To evaluate the efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESS X200) implanted under a scleral flap for the surgical treatment of primary open-angle glaucoma (POAG).


METHODS
Clinical, prospective, noncomparative, nonrandomized study. The efficacy and safety were evaluated on the full sample, with a minimum follow-up of 12 months (maximum 24, mean 18).


METHODS
Thirty-seven eyes of 35 patients.


METHODS
The Ex-PRESS device was implanted under a scleral flap in patients with POAG.


RESULTS
Preoperative intraocular pressure (IOP) was 27.6 (SD 8.7) mm Hg; at last follow-up, IOP was 12.4 (SD 3.4) mm Hg (55.1% reduction). The success rates (IOP < 18 mm Hg and < 15 mm Hg at last visit without medications) were 78.4% (29/37) and 70.3% (26/37), respectively. Kaplan-Meier analyses (probability of IOP < 18 mm Hg and < 15 mm Hg without medications) at last follow-up were 72.6% and 47.9%, respectively. Early postoperative complications were clinically mild and included postoperative IOP < 5 mm Hg: 12 cases at 1 day, 8 cases at 1 week, 3 cases at 1 month, 1 case at 3 months; serous choroidal detachment: 9 cases, of which 3 spontaneously resolved, whereas in 6 cases, hypotony and flat chamber were treated with viscoelastic injection in the anterior chamber. At last follow-up, 6 patients were treated with 2 IOP-lowering medications. No sight-threatening consequences of surgery were observed. There were 8 cases (21.6%, n = 37) of bleb needling.


CONCLUSIONS
Our data support the efficacy and safety of the implantation of this device under a scleral flap. The IOP reduction obtained was significant and long standing and complications were mild.
De Feo
Fabio
F
Centro di Ricerca Clinica e Laboratorio per il Glaucoma e la Cornea, Clinica Oculista, DiNOG, University of Genoa, Viale Benedetto XV 5, Genoa, Italy.
Bagnis
Alessandro
A
Bricola
Graziano
G
Scotto
Riccardo
R
Traverso
Carlo Enrico
CE
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D013508:Ophthalmologic Surgical Procedures; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000379:methods*; D012590:Sclera / Q000601:surgery*; D013193:Stainless Steel; D013524:Surgical Flaps; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D014792:Visual Acuity
D013193:Stainless Steel