N/A
Completed N=400
Clinical Evaluation of a New Viscoelastic for Cataract Surgery
Source: ClinicalTrials.gov NCT00972621 ↗Enrolled (actual)
400
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively — 10.6; 7.6 percentage of participants
Summary
The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively |
10.6; 7.6 | — |
| SECONDARY Postoperative Mean Endothelial Cell Count |
2454.3; 2366.3 | — |
Eligibility Criteria
Inclusion Criteria
- Otherwise healthy eye with no pathology other than the presence of cataract
- Visual potential of 20/40 or better
Exclusion Criteria
- Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
- Known intraocular pressure increases from steroid treatment
- Low endothelial cell count
Data sourced from ClinicalTrials.gov (NCT00972621). 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.