Comparison of the performance and safety of 2 ophthalmic viscosurgical devices in cataract surgery.
To compare the clinical performance and safety of 2 ophthalmic viscosurgical devices (OVDs)-Twinvisc (OVD 1) and Duovisc (OVD 2)-in cataract surgery.



European multicenter study.



Prospective randomized controlled study.



Patients with cataract had phacoemulsification and intraocular lens implantation in 1 eye. They were randomly assigned to receive OVD 1 or OVD 2. Preoperative and postoperative examinations over 3 months included mean intraocular pressure (IOP), incidence of IOP peaks (≥30 mm Hg and ≥24 mm Hg), endothelial cell count (ECC), corneal thickness, and intraocular inflammation. A subjective evaluation of the OVDs was performed.



The study comprised 220 patients. The incidence of IOP peaks and the mean IOP were not statistically significantly different between the 2 groups at any of the follow-up visits. At 6 hours, the incidence of IOP spikes 30 mm Hg or higher was 6.5% and 7.2% in the OVD 1 and the OVD 2 groups, respectively (P = .846). For the IOP spikes 24 mm Hg or higher, the incidence was 16.8% and 25.2%, respectively (P = .128). Three months postoperatively there was no statistically significant difference in ECC and pachymetry between the 2 groups. Mild inflammation was noticed up to 7 days postoperatively after which it resolved in both groups. Subjectively, the OVD 2 was easier to use, whereas the OVD 1 had better cohesive and dispersive properties.



Both OVDs have similar performance and safety profiles in phacoemulsification cataract surgery. No clinically relevant differences were found between the 2 devices regarding transient IOP spikes, mean IOP, corneal endothelium injury, or inflammation.
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Gerd U
GU
Auffarth
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden. Electronic address: florian.auerbach@med.uni-heidelberg.de.
Florian N
FN
Auerbach
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Tanja
T
Rabsilber
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
José A
JA
Gegúndez
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Ricardo
R
Cuiña
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Yves
Y
Renard
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Paolo
P
Vinciguerra
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Fabrizio
F
Camesasca
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Francoise
F
Van Cauwenberge
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Thierry
T
Amzallag
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Gysbert
G
Van Setten
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
Mike P
MP
Holzer
D000368:Aged; D000369:Aged, 80 and over; D000867:Anterior Chamber / Q000187:drug effects; D002452:Cell Count; D002809:Chondroitin Sulfates / Q000008:administration & dosage* / Q000009:adverse effects; D063171:Corneal Pachymetry; D004338:Drug Combinations; D004728:Endothelium, Corneal / Q000166:cytology; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007429:Intraocular Pressure / Q000502:physiology; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011446:Prospective Studies; D014065:Tonometry, Ocular; D055675:Viscosupplements / Q000008:administration & dosage* / Q000009:adverse effects
D004338:Drug Combinations; D055675:Viscosupplements; D006820:Hyaluronic Acid; D002809:Chondroitin Sulfates