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Safety, efficacy, and intraoperative characteristics of DisCoVisc and Healon ophthalmic viscosurgical devices for cataract surgery.

Modi SS, Davison JA, Walters T - Clin Ophthalmol (2011)

Bottom Line: To evaluate the safety and efficacy of DisCoVisc ophthalmic viscosurgical device (OVD, Alcon Laboratories, Inc) with respect to a comparator, Healon OVD (Advanced Medical Optics, Inc).Masked technicians evaluated objective safety parameters of intraocular pressure (IOP) and endothelial cell density, with 90 days of follow-up.DisCoVisc OVD had both cohesive and dispersive properties, and was safe and effective for every stage of cataract surgery.

View Article: PubMed Central - PubMed

Affiliation: Seeta Eye Centers, Poughkeepsie, NY, USA. smodieyes@aol.com

ABSTRACT

Purpose: To evaluate the safety and efficacy of DisCoVisc ophthalmic viscosurgical device (OVD, Alcon Laboratories, Inc) with respect to a comparator, Healon OVD (Advanced Medical Optics, Inc).

Patients and methods: In this prospective study, patients with cataracts were randomized to an OVD, and then received phacoemulsification and injection of an intraocular lens. After each surgery, unmasked investigators completed subjective questionnaires about OVD characteristics during each stage of the procedure. Masked technicians evaluated objective safety parameters of intraocular pressure (IOP) and endothelial cell density, with 90 days of follow-up.

Results: The DisCoVisc OVD group (128 eyes) and the Healon OVD group (121 eyes) had statistically similar outcomes for IOP and for endothelial cell loss. Subjectively assessed viscosity was statistically different (P < 0.0001), with Healon OVD most often rated "cohesive" and DisCoVisc OVD most often rated "both dispersive and cohesive". Workspace maintenance differed between groups (P < 0.0001), with workspace most frequently rated "full chamber maintained" when using DisCoVisc OVD and most frequently rated "workspace maintained" when using Healon OVD. "Flat" or "shallow" workspace ratings occurred only in the Healon OVD group.

Conclusion: DisCoVisc OVD had both cohesive and dispersive properties, and was safe and effective for every stage of cataract surgery.

No MeSH data available.


Related in: MedlinePlus

Mean intraocular pressure. Error bars represent standard deviation. Note break in x-axis. Series are offset in the lateral direction for clarity. Dashed line represents prespecified safety limit.
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f1-opth-5-1381: Mean intraocular pressure. Error bars represent standard deviation. Note break in x-axis. Series are offset in the lateral direction for clarity. Dashed line represents prespecified safety limit.

Mentions: Of the 240 patients without protocol violations, an additional 12 patients (eight in the DisCoVisc OVD group and four in the Healon OVD group) were excluded from IOP analysis. Patients were excluded from the IOP analysis if the IOP measurement at 6 ± 2 hours postoperative was missing or was more than 30 minutes early (ie, if the measurement intended for 4–8 hours postoperative was recorded at 3 hours and 29 minutes postoperative or earlier). The resultant evaluable population was 115 eyes in the DisCoVisc OVD group and 113 eyes in the Healon OVD group. Mean IOPs with time are shown in Figure 1. Mean IOPs were statistically similar between OVD groups at all time points. All mean IOPs were at least 8 mmHg lower than the prespecified safety limit of 30 mmHg.


Safety, efficacy, and intraoperative characteristics of DisCoVisc and Healon ophthalmic viscosurgical devices for cataract surgery.

Modi SS, Davison JA, Walters T - Clin Ophthalmol (2011)

Mean intraocular pressure. Error bars represent standard deviation. Note break in x-axis. Series are offset in the lateral direction for clarity. Dashed line represents prespecified safety limit.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3198411&req=5

f1-opth-5-1381: Mean intraocular pressure. Error bars represent standard deviation. Note break in x-axis. Series are offset in the lateral direction for clarity. Dashed line represents prespecified safety limit.
Mentions: Of the 240 patients without protocol violations, an additional 12 patients (eight in the DisCoVisc OVD group and four in the Healon OVD group) were excluded from IOP analysis. Patients were excluded from the IOP analysis if the IOP measurement at 6 ± 2 hours postoperative was missing or was more than 30 minutes early (ie, if the measurement intended for 4–8 hours postoperative was recorded at 3 hours and 29 minutes postoperative or earlier). The resultant evaluable population was 115 eyes in the DisCoVisc OVD group and 113 eyes in the Healon OVD group. Mean IOPs with time are shown in Figure 1. Mean IOPs were statistically similar between OVD groups at all time points. All mean IOPs were at least 8 mmHg lower than the prespecified safety limit of 30 mmHg.

Bottom Line: To evaluate the safety and efficacy of DisCoVisc ophthalmic viscosurgical device (OVD, Alcon Laboratories, Inc) with respect to a comparator, Healon OVD (Advanced Medical Optics, Inc).Masked technicians evaluated objective safety parameters of intraocular pressure (IOP) and endothelial cell density, with 90 days of follow-up.DisCoVisc OVD had both cohesive and dispersive properties, and was safe and effective for every stage of cataract surgery.

View Article: PubMed Central - PubMed

Affiliation: Seeta Eye Centers, Poughkeepsie, NY, USA. smodieyes@aol.com

ABSTRACT

Purpose: To evaluate the safety and efficacy of DisCoVisc ophthalmic viscosurgical device (OVD, Alcon Laboratories, Inc) with respect to a comparator, Healon OVD (Advanced Medical Optics, Inc).

Patients and methods: In this prospective study, patients with cataracts were randomized to an OVD, and then received phacoemulsification and injection of an intraocular lens. After each surgery, unmasked investigators completed subjective questionnaires about OVD characteristics during each stage of the procedure. Masked technicians evaluated objective safety parameters of intraocular pressure (IOP) and endothelial cell density, with 90 days of follow-up.

Results: The DisCoVisc OVD group (128 eyes) and the Healon OVD group (121 eyes) had statistically similar outcomes for IOP and for endothelial cell loss. Subjectively assessed viscosity was statistically different (P < 0.0001), with Healon OVD most often rated "cohesive" and DisCoVisc OVD most often rated "both dispersive and cohesive". Workspace maintenance differed between groups (P < 0.0001), with workspace most frequently rated "full chamber maintained" when using DisCoVisc OVD and most frequently rated "workspace maintained" when using Healon OVD. "Flat" or "shallow" workspace ratings occurred only in the Healon OVD group.

Conclusion: DisCoVisc OVD had both cohesive and dispersive properties, and was safe and effective for every stage of cataract surgery.

No MeSH data available.


Related in: MedlinePlus