Phase 4
Completed N=28
Intraoperative Floppy Iris Syndrome
Cataract · Floppy Iris Syndrome
Source: ClinicalTrials.gov NCT00711347 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Corneal Endothelial Cell Loss — 9.85; -3.68 Percent change
Summary
An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Endothelial Cell Loss |
9.85; -3.68 | — |
| SECONDARY Intraocular Pressure (IOP) |
16.93; 20.29 | — |
| SECONDARY Aqueous Signs - Cells |
0.93; 1.14 | — |
| SECONDARY Aqueous Signs - Flare |
0.43; 0.69 | — |
| SECONDARY Aqueous Signs - Edema |
0.57; 0.79 | — |
| SECONDARY Surgeon Survey |
1.9; 2.5; 4.6; 3.6; 2.9; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosed with floppy iris syndrome
- operable bilateral cataracts
Exclusion Criteria
- Intraocular Pressure (IOP) > 21mmHg
- ocular inflammatory disease
- systemic or ocular diseases affecting Endothelial Cell Count
Data sourced from ClinicalTrials.gov (NCT00711347). 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.