Phase 3
Completed N=224
DisCoVisc Comparative Evaluation
Cataracts
Source: ClinicalTrials.gov NCT00732225 ↗
Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Percent Loss of Endothelial Cells — 9.48; 15.66; 23.69; 25.70 Percent Loss
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.
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 | — |
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
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. Informational only — not medical advice.