Safety And Effectiveness Of Ophthalmic Visco-Surgical Device Containing Free Radical Scavenging Sorbitol In Cataract Patients With Corneal Endothelial Disease

To evaluate the safety and effectiveness of a new visco-surgical device (OVD) containing free radical scavenging sorbitol (Ophtheis FRPro: 3% Sodium hyalorunate + 4% Sorbitol) compared with dispersive OVD (Viscoat: 3% sodium hyaluronate, +4% Chondroitin Sulfate), when used in cataract surgery in patients with endothelial disease.

Prospective randomized 1:1 study (Ophtheis FR Pro:Viscoat); stratified by age group, preoperative endothelial cell count, cataract severity and surgical method.

Patients aged 65 years or older with endothelial disease and age-related cataract treated with standard phacoemulsification cataract extraction or femtosecond-laser assisted cataract surgery (FLACS) were included. Patients were randomized to receive either Ophtheis FRPro or Viscoat. Intraoperative equivalent ultrasound power (EqUSP) and ultrasound time (TUT) were compared between Phaco and FLACS groups. Postoperative visits were at 24 hours, 7 days, 1 month, and 3 months. Level of endothelial cell density (ECD), coefficient of variation (CV),  central corneal thickness (CCT), visual acuity, and complications were analyzed.

80 patients were randomized: 40 patients in the Ophtheis FR Pro group (20 Phaco + 20  FLACS eyes) and 40 patients in the Viscoat group (20 Phaco + 20  FLACS eyes). Both the EqUSP and TUT were significanty lower in FLACS compared to standard Phaco surgery (10.6% vs 24.3% and 36.2 vs 44.35 sec, repectively). Ophtheis FR Pro was noninferior to Viscoat in mean percentage of ECD loss from baseline to 3 months in standard Phaco cases (29 ± 6 % and 27±8% respectively). In FLACS cases, ECD loss was lower regardless whether Ophtheis FR Pro (15.6% ± 9%) or Viscoat (14% ± 8%) was used to protect the endothelium. No significant differences were found with regard to changes in CV, CCT, and visual acuity regardless of OVD used per each surgical method.

Ophtheis FR Pro OVD provides surgeons with a new option of corneal endothelial protection from phaco induced trauma in patients with endothelial disease.