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.
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00763360
First received: September 26, 2008
Last updated: December 20, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: DisCoVisc® Drug: Healon Drug: Amvisc Plus |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery. |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Endothelial Cell Count Change From Baseline [ Time Frame: one month ] [ Designated as safety issue: Yes ]Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
- Investigator Reported Space Maintenance [ Time Frame: During surgical procedure ] [ Designated as safety issue: No ]Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.
Secondary Outcome Measures:
- Change in Corneal Thickness [ Time Frame: 1 month ] [ Designated as safety issue: No ]Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.
- Corneal Clarity [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.
| Enrollment: | 184 |
| Study Start Date: | May 2008 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DisCoVisc®
DisCoVisc® Ophthalmic Viscosurgical Device
|
Device: DisCoVisc®
Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure
|
|
Active Comparator: Healon
Healon
|
Drug: Healon
Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure
|
|
Active Comparator: Amvisc Plus
Amvisc Plus
|
Drug: Amvisc Plus
Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure
|
Eligibility| Ages Eligible for Study: | 49 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00763360 History of Changes |
| Other Study ID Numbers: | AUS-S-07-01 |
| Study First Received: | September 26, 2008 |
| Results First Received: | December 20, 2011 |
| Last Updated: | December 20, 2011 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Alcon Research:
|
Cataract |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013