Cutting Edge Glaucoma - Issue 2

TWO-YEAR RESULTS OF A MULTICENTER STUDY OF THE AB INTERNO GELATIN IMPLANT IN MEDICALLY... • 27  countries (Austria, Belgium, England, Germany, Italy, Poland, Spain, and Switzerland). The study complied with Good Clinical Practice/International Council for Harmonisation Guidelines, the Declaration of Helsinki, and all applicable country-specific regulations governing the conduct of clinical research, depending on which provided greater protection to the individual. The protocol was approved by an independent ethics committee prior to study start, and all patients were to provide written informed consent before initiating treatment. Study Population The inclusion criteria were as follows: diagnosis of moderate POAG (defined by a mean devia- tion score between − 3 and − 12 dB) uncontrolled on topical therapy; medicated IOP ≥ 18 and ≤ 33 mmHg; use of one to four topical IOP-lowering medications; area of healthy, free, and mobile conjunctiva in the target quadrant; Shaffer angle grade ≥ 3 in the target quadrant; ≥ 18 years of age; signed written informed consent; and availability, willingness, and sufficient cognitive aware- ness to comply with the examination procedures and schedule. Exclusion criteria included a diagnosis of any glaucoma other than POAG; prior incisional glaucoma surgery (prior iridotomy was acceptable if angles were open); prior cataract surgery in the study eye ≤ 3 months before study treatment; presence of scarring, prior surgery, or other pathologies in the conjunctiva (target quadrant); history of corneal surgery/disease; central corneal thickness ≤ 490 or ≥ 620 μm; presence of vitreous in the anterior chamber; presence of intraocular silicone oil; clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit; active ophthalmic disease/disorder that could confound study results; impaired episcleral venous drainage; and known or suspected allergy/sensitivity to drugs required for the implantation (including anesthesia), or any of the device components (e.g., bovine or porcine products, and glutaraldehyde). Both eyes could be implanted (study eyes) provided they met the eligibility criteria and sur- geries for each eye were performed at least 30 days apart. Perioperative Procedures The gelatin implant was placed ab interno either as a stand alone procedure (implant alone) or in combination with cataract surgery (phaco + implant), based on whether the surgeon and patient deemed cataract surgery necessary at the time of glaucoma surgery. Consistent with typical clinical practice, investigators could adjust the preoperative medi- cation regimen as believed necessary/appropriate. Recommendations included a topical steroid (prednisolone acetate 1% or equivalent, or benzalkonium chloride [BAK]-free difluprednate 0.05%) four times daily (QID) in the study eye one week before surgery, and a topical antibiotic (fluoroquinolone or equivalent, preferably BAK-free) QID on day − 1 (preoperative). Topical (in the study eye) or systemic IOP-lowering medications were to be suspended on day 0 (surgery day). The surgery was performed using standard ophthalmic operating techniques and perioperative medications (including anesthesia), as customary for the investigator. Adjunctive