Phase 3 N=224 Single-blind Treatment

DisCoVisc Comparative Evaluation

Cataracts

Bottom Line

View on ClinicalTrials.gov: NCT00732225 ↗

Enrolled (actual)

224

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: Primary: Percent Loss of Endothelial Cells — 9.48; 15.66; 23.69; 25.70 Percent Loss

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DisCoVisc (Device); DuoVisc (Device); BioVisc (Device); Healon5 (Device); Amvisc Plus (Device)
Age: Adult, Older Adult · 49+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Loss of Endothelial Cells	9.48; 15.66; 23.69; 25.70; 23.04	—
SECONDARY Aqueous Signs - Corneal Edema	81.33; 78.05; 37.50; 63.64; 54.55; 14.67	—
SECONDARY Aqueous Signs - Aqueous Flare	76.00; 75.61; 41.67; 63.64; 54.55; 21.33	—
SECONDARY Aqueous Signs - Aqueous Cells	84.00; 80.49; 45.83; 63.64; 56.36; 16.00	—
SECONDARY Intraocular Pressure (IOP)	17.67; 17.78; 20.32; 19.88; 16.96	—
SECONDARY Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy	0.00; 0.00; 0.00; 0.00; 0.00; 2.70	—
SECONDARY Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification	0.00; 0.0; 0.00; 0.00; 0.00; 0.00	—
SECONDARY Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—

Summary

A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.

Eligibility Criteria

Inclusion Criteria

Unilateral operable cataracts

Exclusion Criteria

Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
Intraocular Pressure (IOP) > 21
History of ocular inflammation
Systemic or ocular diseases affecting corneal endothelium

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00732225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.