To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior… (NCT00763360) | Clinical Trial Compass
CompletedPhase 4
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.
United States184 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range
49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 comp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.