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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

Box plot of percentage change in endothelial cell density from baseline to 90 days postoperative. Bold lines within the boxes represent the median; upper limits of the boxes represent the first quartile; lower limits of the boxes represent the third quartile; and error bars represent the maxima and minima.
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f2-opth-5-1381: Box plot of percentage change in endothelial cell density from baseline to 90 days postoperative. Bold lines within the boxes represent the median; upper limits of the boxes represent the first quartile; lower limits of the boxes represent the third quartile; and error bars represent the maxima and minima.

Mentions: Of the 240 patients without protocol violations, one patient in the Healon OVD group was excluded from the endothelial cell density analysis because the image of her eye was captured at the peripheral cornea instead of the central corneal. For the remaining evaluable 116 Healon OVD patients and 123 DisCoVisc OVD patients, the percentage loss of endothelial cell density from baseline to postoperative day 90 was lower for eyes in the DisCoVisc OVD group (average 6.4% loss, with a 95% confidence interval [CI] range: ±2.3% loss) than for eyes in the Healon OVD group (average 8.8% loss, with a 95% CI range: ±2.3%). The percentage loss of endothelial cell density was not statistically different between groups (P = 0.15 by analysis of variance). The distribution – minimum, median, maximum, and quartiles – of percentage loss of endothelial cell density is shown in Figure 2.


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

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

Box plot of percentage change in endothelial cell density from baseline to 90 days postoperative. Bold lines within the boxes represent the median; upper limits of the boxes represent the first quartile; lower limits of the boxes represent the third quartile; and error bars represent the maxima and minima.
© Copyright Policy
Related In: Results  -  Collection

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

f2-opth-5-1381: Box plot of percentage change in endothelial cell density from baseline to 90 days postoperative. Bold lines within the boxes represent the median; upper limits of the boxes represent the first quartile; lower limits of the boxes represent the third quartile; and error bars represent the maxima and minima.
Mentions: Of the 240 patients without protocol violations, one patient in the Healon OVD group was excluded from the endothelial cell density analysis because the image of her eye was captured at the peripheral cornea instead of the central corneal. For the remaining evaluable 116 Healon OVD patients and 123 DisCoVisc OVD patients, the percentage loss of endothelial cell density from baseline to postoperative day 90 was lower for eyes in the DisCoVisc OVD group (average 6.4% loss, with a 95% confidence interval [CI] range: ±2.3% loss) than for eyes in the Healon OVD group (average 8.8% loss, with a 95% CI range: ±2.3%). The percentage loss of endothelial cell density was not statistically different between groups (P = 0.15 by analysis of variance). The distribution – minimum, median, maximum, and quartiles – of percentage loss of endothelial cell density is shown in Figure 2.

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