Phase 4
Completed N=112
DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
Source: ClinicalTrials.gov NCT00712244 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcomePrimary: Corneal Endothelial Cell Loss — 1.51; 1.18; 4.72; 6.30 Percent Change
Summary
A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Endothelial Cell Loss |
1.51; 1.18; 4.72; 6.30 | — |
| SECONDARY Percent Gain in Corneal Thickness. |
2.89; 7.02; 9.92; 5.06; -0.55; -1.06 | — |
| SECONDARY Aqueous Signs - Corneal Edema |
68.97; 75; 57.69; 65.38; 57.59; 21.43 | — |
| SECONDARY Aqueous Signs - Aqueous Flare |
20.69; 39.29; 26.92; 46.15; 75.86; 53.57 | — |
| SECONDARY Aqueous Signs - Aqueous Cells |
6.9; 14.29; 7.69; 7.69; 65.52; 46.43 | — |
| SECONDARY Intraocular Pressure (IOP) |
21.58; 19.48; 20.72; 18.65 | — |
| SECONDARY Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy |
0; 0; 0; 0; 3.45; 3.57 | — |
| SECONDARY Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- operable cataracts in at least one eye
Exclusion Criteria
- Endothelial Cell Count (ECC) ≤1500cells/mm2
- Intraocular Pressure (IOP) > 21mm Hg
- previous ocular inflammation
- systemic or ocular conditions affecting corneal endothelium
Data sourced from ClinicalTrials.gov (NCT00712244). 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. Informational only — not medical advice.