Phase 4
N=184
To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00763360 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Endothelial Cell Count Change From Baseline — -7.91; -5.11; -4.92 Percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- DisCoVisc® (Device); Healon (Drug); Amvisc Plus (Drug)
- Age
- Adult, Older Adult · 49+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Cell Count Change From Baseline |
-7.91; -5.11; -4.92 | — |
| PRIMARY Investigator Reported Space Maintenance |
59; 26; 61; 2; 26; 1 | — |
| SECONDARY Change in Corneal Thickness |
0.53; 0.54; 0.53 | — |
| SECONDARY Corneal Clarity |
2; 2; 1; 53; 54; 59 | — |
Summary
The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Patients able to understand and sign a document of informed consent;
- Patients aged ≥49 years with age-related cataract formation;
- Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
- Patients that have healthy eyes excluding the formation of cataract.
Exclusion Criteria
- pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
- A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
- Iris atrophy in the operative eye;
- Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
- Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
- Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam;
- Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
- Baseline endothelial cell density < 1500 cells/mm2, in the operative eye;
- Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
- Patients 48 years of age or younger;
- Proliferative diabetic retinopathy in the operative eye;
- Uncontrolled diabetes mellitus;
- Marfan's Syndrome;
- An ocular disease and/or condition that may compromise results;
- A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
- Lens for the correction of astigmatism may be performed;
- Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
- A non-functional fellow eye;
- Participation in any other clinical study within the 30 days before surgery
Data sourced from ClinicalTrials.gov (NCT00763360). 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.